At least 67 people have died in 20 outbreaks caused by contaminated drugs since 2001, experts told a Senate hearing Thursday. The Food and Drug Administration says there have likely been more cases than that, but they have no way of telling now.

Iowa Senator Tom Harkin says he believes the Senate is close to getting legislation that would give the FDA specific control over large pharmacies like the one behind the outbreak of fungal meningitis that’s killed 55 people so far. The hope is to prevent any more of these outbreaks.

“We must have changes or this is going to happen again,” Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, told a hearing of the Senates Health, Education, Labor and Pensions Committee Thursday. Harkin, a Democrat, chairs the committee.

“This tragedy was only the worst in a series of incidents involving compounded products,” Woodcock added. “In retrospect, FDA should have been more aggressive… We are being more aggressive now.”

More than 740 people have been sickened in the outbreak of disease linked to contaminated products distributed by the New England Compounding Center in Massachusetts last year. At latest count, the Centers for Disease Control and Prevention says, 55 have died from a rare form of meningitis caused by mold-contaminated steroid injections.

The Pew Charitable Trusts ran down some recent incidents and came up with 19 other compounding pharmacy errors that led to 22 deaths since 2001. And at least 38 patients were blinded or suffered vision loss because of contaminated eye injections.

The cases include three people killed and 11 sickened in California in 2001 from contaminated injections of a steroid called betamethasone. Five had bacterial meningitis. They also include overdoses from saline solutions that had too much sodium and bloodstream infections from various contaminated infusion products.

"I think it's unconscionable that we have failed to regulate this industry for so long and I am committed to moving forward," Sen. Elizabeth Warren, a Massachusetts Democrat, said at the hearing. But previous efforts to give the FDA more power have fallen apart, most recently in 2007. Tennessee Sen. Lamar Alexander, a Republican, said lobbying by the compounding pharmacy pressured lawmakers into dropping the legislation.

Inspections of NECC showed many of its products were contaminated with fungus and bacteria. The operation has been closed down and the FDA and several states have stepped up inspections of large-scale pharmacies.

The FDA says the problem has arisen because so many compounding pharmacies have become major manufacturers of products from saline solution to chemotherapy drugs. They were originally licensed to whip up treatments on a prescription-by-prescription basis, but many now make products far in advance of their being prescribed, and ship them all over the country.

What has not been clear is who regulates them, and the FDA says many of these operations use the lack of clear regulation as an excuse to fend off efforts to inspect them and see their records. States are supposed to regulate traditional pharmacies, including compounding pharmacies. FDA regulates large drug manufacturers.

The Senate legislation, proposed by the FDA, would create a third category – large-scale compounders – that it would regulate.

State pharmacy boards said they’d support the new legislation. “We agree with the FDA that the situation can and will happen again,” Carmen Catizone, executive director of the National Association of Boards of Pharmacy, told the hearing. He did question one part of the proposed law – allowing FDA to get into the records of pharmacies regulated by states, saying it could cause confusion.

The consumer group Public Citizen opposes the new legislation, saying the FDA has all the authority it ever needed to stop rogue compounding pharmacies, but has failed to act. Woodcock says this isn’t true and says pharmacies regularly defy the agency when it tries to inspect facilities and their records.

“We need to get into pharmacies to make sure they are not posing as traditional pharmacies,” she told the hearing. “Sometimes, if there is an outbreak, we get reports and they say, ‘no you can’t come into our pharmacy’. “ Without seeing records, Woodcock says, FDA can’t tell where a contaminated drug may have been shipped.

This, in turn, makes it hard to track outbreaks. A person with a complication caused by a contaminated drug may not even know which product caused it.

Pew supports prioritized oversight of sterile products, notes there are a number of areas it would miss. These include non-sterile compounded drugs, such as compounded “bioidentical” hormone replacement pills. ”Compounded oral dosage forms have the potential to cause harm by both impurities and sub- or super-potency,” Pew’s Allan Coukell told the hearing.

It would also leave large pharmacies that don’t ship their products out of state free to operate under the FDA’s radar, Coukell noted.

Related:

• FDA inspection prompts recall by Florida pharmacy
• Months after outbreak, patients still being newly diagnosed
• Agencies do battle with pharmacies after outbreak
• We didn't have power to stop fungal meningitis, FDA says

By Matthew Perrone 
AP

The Food and Drug Administration warned doctors and pharmacists Wednesday to avoid drugs made by a Florida specialty pharmacy called The Compounding Shop, due to potential safety problems uncovered by health inspectors. 

The St. Petersburg, Fla.-based pharmacy has agreed to recall all of its sterile drugs and is in the process of notifying customers, the FDA said in a statement. The agency said health care professionals should quarantine drugs from the company and not administer them to patients.

The Compounding Shop is a compounding pharmacy, which means it mixes custom formulations of drugs to meet doctors' specifications. In recent weeks the FDA has cracked down on compounding pharmacies across the country, triggering several national recalls.

The wave of inspections comes in the wake of a nationwide fungal meningitis outbreak last year tied to contaminated drugs from a Massachusetts pharmacy. The outbreak has killed 55 people and made 741 Americans sick with either fungal meningitis or infections at the site where they were injected.

The FDA said a recent inspection of The Compounding Shop raised concerns about sterility problems with company drugs that could lead to bacterial contamination. 

"If an injectable drug product that is intended to be sterile is contaminated, it could result in a life-threatening infection in patients," said Janet Woodcock, director of FDA's drug center, in a statement.

Patients who received products form the pharmacy and have concerns should contact their doctor. 

By Toni Clarke
Reuters

A federal judge criticized the U.S. Food and Drug Administration over its refusal to make emergency contraception available to girls of all ages without a prescription, saying the agency's move to restrict distribution to consumers aged 15 and older was not realistic. 

U.S. District Judge Edward Korman on April 5 ordered the FDA to lift age restrictions on all levonorgestrel-based emergency contraception - also known as the "morning-after" pill or "Plan B" - to prevent unwanted pregnancies.

At a hearing in Brooklyn, New York, on Tuesday, he said he would rule by the end of the week on the FDA's request to stay the order, which is slated to take effect May 10. The FDA has appealed the ruling to the 2nd U.S. Circuit Court of Appeals in Manhattan.

"I do think there is a principle that is a dangerous one of a court ordering the FDA to approve a drug," FDA Commissioner Margaret Hamburg told the Reuters Health Summit in New York on Monday ahead of the hearing. "You have to step back and look at this not just in terms of Plan B but in terms of the precedent."

Late last month, the FDA said it would allow girls as young as 15 years old to buy Plan B One-Step contraception, made by a unit of Teva Pharmaceutical Industries Ltd, without a prescription. Cashiers will still have to verify the customer's age before selling it. The agency said the move was based on data provided by Teva that showed girls of that age could safely use the drug without the intervention of a healthcare provider.

Korman called the decision "a lot of nonsense," saying that 15- and 16-year-olds may not have photo identification needed to buy the drug.

The judge noted that the FDA's restrictions still apply to other forms of emergency contraception, including a two-pill version of Plan B and its generic equivalents. These are only available to women 17 and older with identification.

Korman also questioned the timing of the decision, made one day before the FDA filed its notice of appeal of the April order.

"I'm convinced the only reason you decided it when it was decided was to sugarcoat this appeal," Korman told a lawyer for the FDA, Farzin Franklin Amanat.

A lawyer for the plaintiffs, Janet Crepps of the Center for Reproductive Rights, countered that the different access rules for Plan B One-Step and other forms of emergency contraception had created a "convoluted" system for girls and women seeking the drug in its brand name and generic forms.

"That's what happens when you let politicians instead of scientists make these decisions," Korman replied.

Emergency contraceptives generally sell for $10 to $80. Although they can work as long as 120 hours after unprotected sex, they are most effective in the first 24 hours.

Asked about the ongoing court case, Teva Chief Executive Jeremy Levin said the company provides medicines where they are needed.

"I'm not interested in getting into politics," he told the Reuters Health Summit. "The bottom line is that we believe we are providing an important medicine."

The Food and Drug Administration is stepping up pressure on firms that make drugs for specific individuals, known as compounding pharmacies, as it seeks greater regulatory authority following a deadly meningitis outbreak traced to one such pharmacy. 

On Thursday, the agency posted reports on its web site for 28 of 31 compounding pharmacies it inspected between February and April listing a raft of violations ranging from inappropriate clothing for sterile drug processing to insufficient testing for contaminants.

In two cases the FDA said its inspections were delayed because investigators were forced to obtain search warrants. Several other pharmacies attempted to block access to records. The agency said it is reviewing the information obtained during the inspections and will take enforcement action "as appropriate."

But the agency reiterated its position that it does not have enough authority to always take enforcement action following inspections unless specific violations have taken place, such as the distribution of a contaminated drug -- a claim some Republican lawmakers question.

Compounding pharmacies are supposed to provide individually mixed drugs for specific patients who might not be able to get a product elsewhere or in the right format. Over the past decade some of these firms have burst out of that limited role and now ship large volumes of product to hospitals and doctors across the country, taking on, in the process, some of the characteristics of a traditional, regulated pharmaceutical company.

The release of the inspection reports comes five days before a congressional hearing into the meningitis outbreak traced to the Framingham, Massachusetts-based New England Compounding Center (NECC) that killed more than 50 people and sickened hundreds. The hearing, by the House Committee on Energy and Commerce, will be the second held on the matter.

In November, the FDA's commissioner, Dr. Margaret Hamburg, testified before the same committee that ambiguities in the law had inhibited its ability to take aggressive enforcement action against compounding pharmacies, which are mostly regulated by the states. Republican lawmakers argued that the agency has plenty of authority but failed to use it in a way that could have prevented the meningitis outbreak.

The FDA issued a warning letter to NECC in 2006 following an inspection four years earlier that had revealed problems. Yet it failed to follow up on the warning. Hamburg told the committee in November that NECC repeatedly challenged the agency's authority.

On Thursday a group of Democratic lawmakers urged the Committee in a letter to invite the head of the International Academy of Compounding Pharmacists (IACP), an industry association, to testify at Tuesday's hearing.

"The hearing will focus on why FDA has not acted more forcefully to protect the public from the risks of improperly compounded drugs," the letter said. "Internal IACP documents provided to the Committee reveal that for almost two decades, the organization lobbied aggressively and successfully to restrict FDA authority over compounding pharmacies, even when top IACP leaders were aware of significant public health risks from compounding."

Last month the IACP wrote to members of the Senate Committee on Health, Education, Labor and Pensions in a bid to head off any attempt to allow the FDA to determine whether a firm should be classed as a compounding pharmacy and which pharmaceuticals company. That authority, the letter said, "should and must remain exclusively" with the states. 

Related stories: 

• After fungal meningitis outbreak, agencies do battle with pharmacies
• FDA ponders new rules after deadly outbreak
• Nurse spotted mold-tainted drugs right away, hospital says

The biggest thing in operating rooms these days is a million-dollar, multi-armed robot named da Vinci, used in nearly 400,000 surgical procedures nationwide last year — triple the number just four years earlier.

But now the high-tech helper is under scrutiny over reports of problems, including several deaths that may be linked with it and the high cost of using the robotic system.

There also have been a few disturbing incidents: a robotic hand that wouldn't let go of tissue grasped during surgery and a robotic arm hitting a patient in the face as she lay on the operating table.

Is it time to curb the robot enthusiasm?

Some doctors say yes, concerned that the "wow" factor and heavy marketing have boosted use. They argue that there is not enough robust research showing that robotic surgery is at least as good or better than conventional surgery.

Many U.S. hospitals promote robotic surgery in patient brochures, online and even on highway billboards. Their aim is partly to attract business that helps pay for the costly robot.

The da Vinci is used for operations that include removing prostates, gallbladders and wombs, repairing heart valves, shrinking stomachs and transplanting organs. Its use has increased worldwide, but the system is most popular in the United States.

"We are at the tip of the iceberg. What we thought was impossible 10 years ago is now commonplace," said Dr. Michael Stifelman, robotic surgery chief at New York University's Langone Medical Center.

For surgeons, who control the robot while sitting at a computer screen rather than standing over the patient, these operations can be less tiring. Plus robot hands don't shake. Advocates say patients sometimes have less bleeding and often are sent home sooner than with conventional laparoscopic surgery and operations involving large incisions.

But the Food and Drug Administration is looking into a spike in reported problems during robotic procedures. Earlier this year, the FDA began a survey of surgeons using the robotic system. The agency conducts such surveys of devices routinely, but FDA spokeswoman Synim Rivers said the reason now "is the increase in number of reports received" about da Vinci.

Reports filed since early last year include at least five deaths.

Whether there truly are more problems recently is uncertain. Rivers said she couldn't quantify the increase and that it may simply reflect more awareness among doctors and hospitals about the need to report problems. Doctors aren't required to report such things; device makers and hospitals are.

It could also reflect wider use. Last year there were 367,000 robot operations versus 114,000 in 2008, according to da Vinci's maker, Intuitive Surgical Inc. of Sunnyvale, Calif.

Da Vinci is the company's only product, and it's the only robotic system cleared for soft-tissue surgery by the FDA. There are other robotic devices approved for neurosurgery and orthopedics, among other things.

A search for the company's name in an FDA database of reported problems related to medical devices brings up 500 reports since Jan. 1, 2012. Many of those came from Intuitive Surgical. The reports include incidents that happened several years ago and some are duplicates. There's also no proof any of the problems were caused by the robot, and many didn't injure patients. Reports filed this year include:

— A woman who died during a 2012 hysterectomy when the surgeon-controlled robot accidentally nicked a blood vessel.

— A Chicago man who died in 2007 after spleen surgery.

— A New York man whose colon was allegedly perforated during prostate surgery. Da Vinci's maker filed that report after seeing a newspaper article about it and said the doctor's office declined to provide additional information.

— A robotic arm that wouldn't let go of tissue grasped during colorectal surgery on Jan. 14. "We had to do a total system shutdown to get the grasper to open its jaws," said the report filed by the hospital. The report said the patient was not injured.

— A robotic arm hit a patient in the face during a hysterectomy. The company filed that report, and said it is unknown if the patient was injured but that the surgeon decided to switch to an open, more invasive operation instead.

Intuitive Surgical filed all but one of those reports.

Complications can occur with any type of surgery, and so far it's unclear if they are more common in robotic operations, but that's part of what the FDA is trying to find out.

Intuitive Surgical disputes there's been a true increase in problems and says the rise reflects a change it made last year in the way it reports problems.

The da Vinci system "has an excellent safety record with over 1.5 million surgeries performed globally, and total adverse event rates have remained low and in line with historical trends," said company spokeswoman Angela Wonson.

But an upcoming research paper suggests that problems linked with robotic surgery are underreported. They include cases with "catastrophic complications," said Dr. Martin Makary, a Johns Hopkins surgeon who co-authored the paper.

"The rapid adoption of robotic surgery ... has been done by and large without the proper evaluation," Makary said.

The da Vinci system, on the market since 2000, includes a three- or four-armed robot that surgeons operate with hand controls at a computer system located several feet away from the patient. They see inside the patient's body through a tiny video camera attached to one of the long robot arms. The other arms are tipped with tiny surgical instruments.

Robotic operations are similar to conventional laparoscopy, or "keyhole" surgery, which involves small incisions and camera-tipped instruments controlled by the surgeon's hands, not a robot.

Almost 1,400 U.S. hospitals — nearly 1 out of 4 — have at least one da Vinci system. Each one costs about $1.45 million, plus $100,000 or more a year in service agreements.

The most common robotic operations include prostate removal. Aabout 85 percent of these operations in the U.S. are done with the robot. Da Vinci also is often used for hysterectomies, Wonson said.

Makary says there's no justification for the skyrocketing increase in robotic surgery, which he attributes to aggressive advertising by the manufacturer and hospitals seeking more patients.

He led a study published in 2011 that found 4 in 10 U.S. hospitals promoted robotic surgery on their websites, often using wording provided by the manufacturer. Some of the claims exaggerated the benefits or had misleading, unproven claims, the study said.

Stifelman, the Langone surgeon, said it makes sense for hospitals to promote robotic surgery and other new technology to, but that it doesn't mean that it's the right option for all patients.

"It's going to be the responsibility of the surgeon ... to make sure the patient knows there are lots of options," and to discuss the risks and benefits, he said.

His hospital expects to do more than 1,200 robotic procedures this year, versus just 175 in 2008.

For a few select procedures that require operating in small, hard-to-reach areas, robotic surgery may offer advantages over conventional methods, Makary said. Those procedures include head and neck cancer surgery and rectal surgery.

Some surgeons say the robotic method also has advantages for weight-loss surgery on extremely obese patients, whose girth can make hands-on surgery challenging.

"At the console, the operation can be performed effectively and precisely, translating to superior quality," said Dr. Subhashini Ayloo, a surgeon at the University of Illinois Hospital & Health Sciences System in Chicago.

Ayloo, who uses the da Vinci robot, began a study last year on the effectiveness of doing robotic obesity surgery in patients who need a kidney transplant. Some hospitals won't do transplants on obese patients with kidney failure because it can be risky. In the study, robotic stomach-shrinking surgery and kidney transplants are done simultaneously. Patients who get both will be compared with a control group getting only robotic kidney transplants.

"We don't know the results, but so far it's looking good," Ayloo said.

Aidee Diaz of Chicago was the first patient and was taken aback when told the dual operation would be done robotically.

"At first you would get scared. Everybody says, 'A robot?' But in the long run that robot does a lot of miracles," said Diaz, 36.

She has had no complications since her operation last July, has lost 100 pounds and says her new kidney is working well.

Lawsuits in cases that didn't turn out so well often cite inadequate surgeon training with the robot. These include a malpractice case that ended last year with a $7.5 million jury award for the family of Juan Fernandez, a Chicago man who died in 2007 after robotic spleen surgery. The lawsuit claimed Fernandez's surgeons accidentally punctured part of his intestines, leading to a fatal infection.

The surgeons argued that Fernandez had a health condition that caused the intestinal damage, but it was the first robot operation for one of the doctors and using the device was overkill for an ordinarily straightforward surgery, said Fernandez's attorney, Ted McNabola.

McNabola said an expert witness told him it was like "using an 18-wheeler to go the market to get a quart of milk."

Company spokesman Geoff Curtis said Intuitive Surgical has physician-educators and other trainers who teach surgeons how to use the robot. But they don't train them how to do specific procedures robotically, he said, and that it's up to hospitals and surgeons to decide "if and when a surgeon is ready to perform robotic cases."

A 2010 New England Journal of Medicine essay by a doctor and a health policy analyst said surgeons must do at least 150 procedures to become adept at using the robotic system. But there is no expert consensus on how much training is needed.

New Jersey banker Alexis Grattan did a lot of online research before her gallbladder was removed last month at Hackensack University Medical Center. She said the surgeon's many years of experience with robotic operations was an important factor. She also had heard that the surgeon was among the first to do the robotic operation with just one small incision in the belly button, instead of four cuts in conventional keyhole surgery.

"I'm 33, and for the rest of my life I'm going to be looking at those scars," she said.

The operation went smoothly. Grattan was back at work a week later.

Related:

• Robot surgeons may get upgraded
• Robotic prostate surgery comes with trade-off
• Robots invade the operating room

Pouya Dianat/AP

Shawn Lockhart looks at the meningitis-causing fungus Exserohilum rostratum at the mycotic lab at the Centers for Disease Control and Prevention on Oct. 12, 2012 in Atlanta after the fungal meningitis outbreak.

The Food and Drug Administration says it doesn’t have the power it needs to control compounding pharmacies that have expanded out of their traditional one-patient-at-a-time role to making mass drugs.

But consumer advocates say a recent crackdown by the agency shows it most certainly can – and should. A spate of recent FDA inspections have shown that the dirty conditions that led to an outbreak of fungal meningitis that killed 51 people and sickened more than 700 are anything but rare at pharmacies that mix up what are supposed to be “sterile” injectable drugs.

“We are currently deploying resources to work with states to inspect certain state-licensed pharmacies that produce sterile drug products that we believe may present the highest risk,” FDA commissioner Dr. Margaret Hamburg writes in her latest blog entry. “Over the past two months, we have inspected over 30 facilities and will continue to work to protect public health.”

That's a big step up from the previous pace, when FDA might inspect a facility, write a letter, and wait a few years before following up. Hamburg estimates there are more than 7,000 compounding pharmacies in the U.S.

"We had a list of facilities we have been keeping our eye on," says FDA spokeswoman Erica Jefferson.

The FDA sent Medi-Fare Drug & Home Health Center, Inc. of Blacksburg, S.C., a warning letter earlier this month, pointing out both that it wasn’t preparing products to match prescriptions and that it had “serious deficiencies in your practices for producing sterile drug product, which could lead to contamination of the products, potentially putting patients at risk.”

Other FDA reports this year have pointed out patches of rust at one compounding pharmacy in St. Petersburg, Fla. and sloppy sterility practices at one in Swedesboro, N.J.

It's about time, say some. “That’s the type of activity we were calling for,” says Dr. Michael Carome of the consumer group Public Citizen, which is agitating for the FDA to do more to regulate compounding pharmacies. Public Citizen has argued that the FDA has all the authority it ever needed to stop rogue compounding pharmacies, but has failed to act.

Luckily, so far, there’s not been another outbreak of illness like the one traced to the New England Compounding Center (NECC), in which 51 people have died of fungal meningitis and more than 700 infected after receiving contaminated injection steroids.

“We haven’t seen any other large-scale scale compounding outbreaks,” Dr.  Michael Bell, acting director of the division of health care quality promotion at the Centers for Disease Control and Prevention, told NBC News. He says there’s a steady stream of requests from states to check, however.

The FDA is openly telling the pharmacies and drug manufacturers it regulates that things have changed since the outbreak tied to NECC. Hamburg was questioned by both House and Senate committees about how the incident could even have happened.

“They appear to have the authority to take actions against companies that engage in drug manufacturing,” Carome said. “What we are going to have to wait to see is will they stand behind the citations of violations they are making,” he added. “That is what they have failed to do previously. Hopefully it’s not just for show.”

Currently, the FDA regulates drug manufacturers, while state boards regulate pharmacies, including compounding pharmacies. But the line between what is a manufacturer and what is a compounding pharmacy can be blurry.

Compounding pharmacies are supposed to mix prescriptions one at a time, on a per-patient basis. But there’s so much demand for special formulations that hundreds of these compounders have started large-scale production. Now, they closely resemble drug manufacturers – but without the very strict oversight and long list of sterility requirements that manufacturers must follow.

Jefferson says the crackdown hasn't gone entirely smoothly. "We still run into situations where a facility has not cooperated with us," she said. "We might not be able to take samples. They might say, 'No, you can't see this.'" Then FDA has to seek help from state authorities.

Mold in IV solution
State officials are also cracking down. But it’s been astute health care professionals who have blown the whistle on the cases of contamination that have been found since the beginning of the year. It was a nurse in Connecticut who earlier this month spotted mold in magnesium sulfate intravenous solution made by New Jersey-based Med Prep Consulting Inc. That pharmacy has since recalled all its products. The firm had received FDA warnings about its sterility practices in 2001 and 2010, agency records showed.

While none of the FDA actions have resulted in recalls yet, some of the state responses have. In Massachusetts, the state board of pharmacy shut down Pallimed Solutions Inc. after an inspection turned up unsterile conditions. The company recalled 16 of its sterile compound products Monday.

On March 21, the FDA announced that Clinical Specialties, based in Augusta, Ga., was recalling all its products after five people who got eye injections of a cancer drug used to treat a degenerative eye condition got serious eye infections.

The FDA had been trying to work cooperatively with pharmacies, in essence making them promise to keep things clean. But not any more, the agency told PharMEDium Services, LLC  of Lake Forest, Illinois last month, after giving the pharmacy a pass since at least 2005. “These events have caused the Agency to reexamine its exercise of enforcement discretion with regard to the need for valid, patient-specific prescriptions,” FDA wrote.

Hamburg has asked Congress for specific authority to regulate these compounders who make products, from bags of saline solution to morphine injections, on a large scale. “In the absence of such legislation, however, the Agency intends to apply its existing legal authorities,” the FDA added.

Hamburg had complained that companies have pushed back against previous FDA attempts to regulate them, creating tangled legal nightmares. Carome agrees it’s possible that the pharmacies have stopped doing that – at least for now.

“Companies have seen what can happen when they harm patients because of contaminated products,” he said. NECC has declared bankruptcy and faces hundreds of lawsuits, as well as criminal prosecution.

“The fungal meningitis outbreak linked to NECC is a situation that no other company wants to go through,” Carome said.

A new tier of regulation
Hamburg wants to create a new tier of regulation to cover large-scale compounders. Public Citizen opposes this idea, saying if they’re acting like manufacturers, they should be regulated as manufacturers.

The recent crackdown shows the agency can act and should have acted against NECC, which had a history of squabbles with regulators, he says. “We believe yes, their argument falls flat,” he said.

Meanwhile, Bell says the CDC and state officials are still dealing with the fallout from NECC. It has asked doctors to keep a close eye on the 14,000 patients who got injections of steroids from the three contaminated batches shipped out by NECC. “We don’t want anyone to fall through the cracks,” Bell said.

“That was overwhelming in scope,” he added. “It is a frightening illustration of what happens when medications are delivered across multiple states to such a wide range of practices in different parts of the country.”

Some of the infections are taking months to show up.  “One (reason) is the medication that was contaminated was a steroid. They turn off inflammation and hide the symptoms of an infection,” Bell said.

But the contamination that’s been found at other pharmacies since would have caused almost immediate symptoms, Bell says. “Within an hour or two (of injection), you are going to turn red. You are going to get signs of inflammation,” he said.

And, he says, CDC has not seen an outbreak like this linked to a drug manufacturer that is regulated as a drug manufacturer.

Related:

FDA ponders new pharmacy rules

Pharmacy owner refuses to testify about outbreak

Pharmacists admit 'sterile' drugs often anything but

A Georgia compounding pharmacy that recalled eye injections earlier this week because of possible contamination is recalling everything it made now.

The Food and Drug Administration says Clinical Specialties of Augusta, Ga., is voluntarily recalling all lots of all sterile products it repackaged and distributed because it cannot assure they are sterile. The agency has cracked down on compounding pharmacies after an outbreak of fungal meningitis and other fungal infections that has affected 722 people and killed 50.

“This expanded recall follows the firm’s initial recall of Avastin on March 18, 2013, due to reports of five patients who have been diagnosed with serious eye infections associated with the use of the product,” the FDA said in a statement.

“The Centers for Disease Control and Prevention (CDC) notified the FDA of these endophthalmitis infections, which occur inside the eyeball. Endophthalmitis after intravitreal injection is a serious complication that can lead to permanent loss of vision. Clinical Specialties Compounding sterile products covered under this recall were distributed nationwide between October 19, 2012 and March 19, 2013.”

The firm was repackaging the cancer drug Avastin for use in treating a degenerative eye condition called macular degeneration. The drug has been shown to help stop progression of the disease.

The drug company Roche, which makes Avastin, makes a version called Lucentis specifically for use in the eye. But Lucentis costs as much as $2,000 per dose, compared to $150 a dose for Avastin when reformulated by a compounding  pharmacist. Roche has complained that repackaging Avastin in this way can lead to contamination and infections.

The FDA says Clinical Specialties isn’t able to ensure that its practices are keeping its products sterile. Inspections at the New England Compounding Center, which caused the fungal meningitis outbreak, showed widespread contamination and poor hygiene.

“Until further notice, health care providers should stop using all sterile products distributed by Clinical Specialties Compounding and return them to the company,” the FDA says.

Related:

• Eye infections prompt Avastin recall
• Nurse spotted mold-tainted drugs right away, hospital says
• Visible mold forces recall of N.J. pharmacy injection drugs
• FDA warns of new batch of fake cancer drug Avastin

Three “male enhancement” products being sold online say they’re all herbal, but they contain hidden prescription drug ingredients and could be dangerous, the Food and Drug Administration said on Thursday.

The three contain compounds similar to the active ingredients in the erectile dysfunction drugs Viagra and Cialis, the FDA said. They can cause serious problems in men being treated for heart disease and should not be taken without a doctor’s supervision.

The names of the three products -- “Rock-It Man”, “Libido Sexual Enhancer” and “Stiff Days” -- leave little doubt what they are supposed to be used for. But while they are marketed as alternatives to the prescription drugs to be used without the guidance of a doctor, they are in fact virtual copies, without any oversight to ensure they are safe.

“FDA laboratory analysis confirmed that ‘Rock-It Man’ contains the undeclared ingredient hydroxythiohomosildenafil.  Hydroxythiohomosildenafil is structurally similar to sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for Erectile Dysfunction (ED),” the FDA says in a statement.

“This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.”

Testing confirmed similar findings in “Libido Sexual Enhancer” and “Stiff Days".

Anyone who has bought any of the products should just toss them, the FDA advises.

“Consumers who have experienced any negative side effects should consult a health care professional as soon as possible,” it adds.

“This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals.  These products are typically promoted for sexual enhancement, weight loss, and body building, and are often represented as being ‘all natural.’  FDA is unable to test and identify all products marketed as dietary supplements on the market that have potentially harmful hidden ingredients.”

Related:

Over 40? Go easy on the extreme workouts, dude

Erectile dysfunction may increase a man's heart woes

Men can get bone disease, too -- but most don't know it

Diners will have to wait a little longer to find calorie counts on most restaurant chain menus, in supermarkets and on vending machines.

Writing a new menu labeling law "has gotten extremely thorny," says the head of the Food and Drug Administration, as the agency tries to figure out who the law should cover.

The 2010 health care law charged the FDA with requiring restaurants and other establishments that serve food to put calorie counts on menus and in vending machines. The agency issued a proposed rule in 2011, but the final rules have since been delayed as some of those non-restaurant establishments have lobbied hard to be exempt.

While the restaurant industry has signed on to the idea and helped to write the new regulations, supermarkets, convenience stores and other retailers that sell prepared food say they want to no part of it.

"There are very, very strong opinions and powerful voices both on the consumer and public health side and on the industry side, and we have worked very hard to sort of figure out what really makes sense and also what is implementable," FDA Commissioner Dr. Margaret Hamburg said in a recent interview with The Associated Press.

Hamburg said menu labeling has turned out to be one of the FDA's most challenging issues, and while requiring calorie counts in some establishments might make sense on paper, "in practice it really would be very hard." She did not say what specific types of establishments she was referring to.

The challenges of putting such a law in place - and deciding whom it should cover  - were made clear Monday when a judge struck down New York City's ban on large sugary drinks. State Supreme Court Justice Milton Tingling said in his ruling that the 16-ounce limit on sodas and other high-calorie drinks arbitrarily applied to only some sweet beverages and some places that sell them. The new limits, championed by Mayor Michael Bloomberg, were supposed to take effect Tuesday.

Hamburg said the FDA is in the final stages of writing the menu labeling regulations and the final rules should come out in the "relative near term." The FDA has tentatively said the rules are due this spring, but that deadline may be optimistic as the food industry and regulators continue to haggle over how they will be written.

The 2011 proposed rules would require chain restaurants with 20 or more locations, along with bakeries, grocery stores, convenience stores and coffee chains, to clearly post the calorie count for each item on their menus. Additional nutritional information would have to be available upon request. The rules would also apply to vending machines if calorie information isn't already visible on the package.

The proposed rules exempted movie theaters, airplanes, bowling alleys and other businesses whose primary business is not to sell food. Alcohol would also be exempted.

Supermarkets and convenience stores are looking for similar exemptions in the final rules. Representatives for the supermarket industry say it could cost them up to a billion dollars to put the rules in place - costs that would be passed on to consumers.

"It's a huge problem for us," says Erik Lieberman of the Food Marketing Institute, which represents retail grocery chains. He says fighting the menu labeling rules is one of his group's top priorities.

Lieberman says the rules could cover thousands of items in each store, going beyond just the prepared foods case and extending to cut fruit, bakery items like pies and loaves of bread and other store items that aren't already packaged and labeled. Lieberman says that means each store has to send all of those items out to labs to be tested, do paperwork to justify the ingredient and nutritional information for each item to the FDA and then create signage and train employees to use it.

Convenience stores say they will have similar problems.

"In a small store like a convenience store that is really putting a lot of signage all over the place," says Jeff Lenard of the National Association of Convenience Stores, referring to the calorie labels. "You just hit a point where words become noise and that's not good."

Nutrition lobbyist Margo Wootan of the Center for Science in the Public Interest says consumer advocates heard the same kind of complaining from the packaged foods industry before they were required to put nutrition information on the backs of food items. Supermarkets and convenience stores should be included because they are breaking more and more into the prepared foods business, she says.

"The supermarket industry is positioning itself as a place to buy prepared items so you don't have to go out to eat or cook," Wootan says, arguing that a rotisserie chicken that is labeled with a calorie count at a takeout restaurant should also be labeled at a grocery store.

The idea of menu labeling is to make sure that customers process the calorie information as they are figuring out what to eat. Many restaurants currently post nutritional information in a hallway, on a hamburger wrapper or on their websites. The new law will make calories immediately available for most items.

Menus and menu boards will also tell diners that a 2,000-calorie diet is used as the basis for general nutrition advice, noting that individual calorie needs may vary.

The labeling requirements were added to the health bill with the support of the restaurant industry, which has faced a patchwork of laws from cities and states. New York City was the first in the country to put a calorie posting law in place. Since then, other cities and states have followed.

Scott DeFife of the National Restaurant Association says the supermarkets are exaggerating how much it would cost them to implement the rules. The restaurant industry has lobbied for the prepared foods in supermarkets and convenience stores to be included, saying they are selling essentially the same things.

DeFife says some convenience stores have even joined the National Restaurant Association as many gas stations now include full restaurants in their stores.

"It's about the food, not the format," he says.

Not all restaurants have been fully supportive, though. A coalition of pizza chains - including Domino's, Papa John's and Pizza Hut franchise holders - have pushed for changes to the proposed rules that would allow more flexibility in how calories are posted because of endless combinations of pizza toppings. The coalition claims there are 34 million ways to order a pizza.

"When you're a small pizza operator trying to get by on tight margins, regulations like this really affect your bottom line, hurting your ability to grow and hire," Domino's Pizza franchisee Jonathan Sharp of Abilene, Texas, said last summer.

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