E-mail updates
Follow on Twitter
Subscribe to RSSIn a move that highlights dilemmas plaguing the U.S. drug supply, federal regulators warned a major manufacturer about problems including bugs in vials of sterile drugs -- insects, literally -- the same day that health officials allowed the firm to ramp up scarce medications for kids with cancer.
Food and Drug Administration officials on Tuesday posted a warning letter sent to APP Pharmaceuticals LLC of Schaumberg, Ill., citing violations at a New York plant that included insects found in clean rooms and in vials of distributed drugs and failure to report defects such as vials contaminated with foreign matter and glass.
The firm also had problems with documenting sterile technique and was marketing unapproved drugs, according to the warning.
“It is apparent that APP Pharmaceuticals LLC’s has failed to implement global corrective actions,” it said.
The letter was dated Feb. 22, the same day that APP announced it had received accelerated FDA approval to market supplies of preservative-free methotrexate to help ease a critical shortage of the medication used to treat childhood leukemia.
Earlier this month, FDA officials and cancer doctors had said the drug was in such short supply, hospitals could have run out within two weeks, jeopardizing life-saving treatment for kids with acute lymphoblastic leukemia, or A.L.L., as well as patients with other illnesses.
“I am delighted that in many cases APP Pharmaceuticals has helped to minimize shortages by significantly increasing our production,” John Ducker, the firm’s president and chief executive said in a statement last week. APP Pharmaceuticals is a subsidiary of the German firm Fresenius Kabi Pharmaceuticals Holding Inc.
The timing was not lost on Erin Fox, manager of the Drug Information Service at the University of Utah, which tracks the nation’s drug shortages.
“This is what I mean when I keep talking about quality issues,” said Fox, citing ongoing manufacturing problems at several U.S. plants, including APP. “All of these companies have had quality issues, yet they make the majority of drugs used in our country.”
The U.S. has logged record numbers of drug shortages in the past two years, fueled in part by sudden closures of drug plants because of problems with contamination, crumbling infrastructure and other issues, FDA documents show.
APP officials said the warning letter, which focused on problems at the firm’s Grand Isle, N.Y., plant, and the company’s efforts to ease the drug shortage crisis were two different issues.
“Methotrexate is not manufactured at the Grand Island plant and, thus, is absolutely unaffected from the warning letter,” Matthias Link, a company spokesman, wrote in an e-mail to msnbc.com.
The violations followed an FDA inspection last summer, June 13 to July 8, and the company had “already begun taking actions on most of the items listed,” Link noted.
“We take all the issues listed in the warning letter very seriously and we are committed to promptly addressing these,” he wrote.
The firm has 15 days from the date of the FDA letter to respond to the problems, including how insects came to be found in an aseptic, or sterile, room used to produce crucial drugs.
“You continued to find insects in your manufacturing area, in finished product (two vials), and you received a complaint for an insect in a distributed vial,” said the letter sent by Ronald M. Pace, director of the FDA’s New York district.
Company officials told FDA inspectors the root cause of the bug problem was with the firm’s supplier of gowns, but they had not scheduled an audit of the firm until six months later, December 2011, the warning said.
FDA officials did not immediately respond to msnbc.com questions about the timing of the warning letter and the expanded approval of APP to make injection-free methotrexate.
Agency officials last week announced they’d narrowly averted two dire shortages: first, the methotrexate scarcity, and then an ongoing shortage of the drug Doxil, used to treat ovarian and other cancers.
The agency licensed a foreign firm, Sun Pharma, temporarily to supply Lipodox, a replacement chemotherapy drug, to the U.S. market.
Balancing the demand for life-saving drugs with the demand that those drugs be safe and sterile is an ongoing challenge, noted Fox.
“Between the shortages and the quality issues, it is difficult to have any kind of confidence in our drug supply,” she said.
Related stories:
Patients cheer as FDA ease shortage of 2 crucial cancer drugs
Hospitals scramble to get scarce kids cancer drug
Amid shortages, rules force hospitals to toss scarce drugs
Leave a Comment:
This really bugs me....
The statement that"most drugs sold in the US is made here.......This is an outright lie. Most generic drugs sold in the US are manufactured in INDIA AND CHINA. This article is short on facts and long on appeasement of the few drug company's making drugs here. It used to be a time when the government actually had INSPECTORS THAT inspected all aspects of our drug making system, they were deleted because the industry told certain lawmakers that they WOULD DO A BETTER JOB WITHOUT SUPERVISION. And because those same "lawmakers" received MANY "favors" from the industry TODAY WE HAVE THE TOTAL PRESCRIPTION MEDICATION MESS. Deregulate them even more is the republicrap mantra, can you afford any more screw ups in your medications?
good old deregulation at its finest. Now we have permission to import alternative medicines from India.
What deregulation? Maybe if the FDA wasn't so busy holding up new drugs from reaching the market in order to protect the pharmicutial corporations while also working overtime to try and prove that marijuana is somehow dangerous and has no medical value they could have been actually doing their real job.
American manufacturing is all about doing the absolute minimum, not "the best". That is why it has failed to compete. Across the board, from food to medications, America has become a dumping ground for contaminated, or, mishandled products from countries like China, India, South America, Taiwan, etc. And this is the tip of the iceburg. Wait until you see what is coming in the next few years as politicians continue to compromise standards and accountability. But wait, we're a democratic capitalistic society? Really? Why are we so ready and willing to let others exploit our own futures? Effectively, that's what is happening. *Slap*---wake the frak up!
Coochie!
That is one of the problems with driving costs down through generics. They have to drive costs down because of reimbursement rates prescribed by Medicare.
The bottom line is that there is high quality, quick delivery and low cost. You can pick any two.
It is well known how to make sterile drugs. Maybe American drug companies are just satisfied with doing as little as they can instead of the best they can. It seems Israel's Teva Pharmaceutical company does a good job of producing safe generic products.
RE: Teva ? Their Israel GMP drug manufacturing facility received a Warning letter from the FDA January 2011... "Food and Drug Administration (FDA) identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug products to be adulterated..."
The Pharmaceutical industry has laid of tens of thousands in recent years. What do you expect would happen? Every business school moron thinks he can 'do more with less'. No, you only get 'less'with less.
Wow, leave it to a reporter to state that there are "bugs" in our meds. Can they get any broader, I am pretty sure there are 1 million types of bugs out there. Exactly what type of bugs are these??
What is disconcerting is that the Companies don't fix the problems on their own, but wait untill discovered by the FDA. Nothing but managerial greed. Too bad the FDA can't give these guys jail time.
Bugs in a clean room? ' I swear they came in on the sterile gowns we bought from Singapore.' The air showers that should be installed between the gowning and production areas, should have gotten the big chunks. I smell fish.
Driving up costs of medicine had nothing to do with it.... BS!
Hey APP, If you put the punch clock outside of the clean area, that would help keep 10-20 employees from stacking up in the air blasters at 7:59 AM.
Hey APP, Clean room does not mean, you have someone come in once a week to empty the trash, dust, clean out the fridge, and vacuum.
Hey APP, Hint the banana peels in the clean room trash cans seem to grow fruit flies automagically.
And everyone wonders why everything is outsourced to Asia countries. Americans are the most lazy @$$ people on the planet and they still whine about how hard life is.
Aren't drug companies wonderful?
When we can't depend on drug companies for drugs, there's only one way out. The Government needs to take charge of drug manufacturing.
James, the government is already in the process of taking over the medical industry. The most lucrative business in the usa. Although this may sound great, there will be a panel of uneducated politics making rules for Dr's to follow, which will lead to crazyness
jsfoo - this already happens with private insurance. Try getting experimental treatment from your insurance company. And they probably define all transplants as experimental.
I guarantee that the person who reviews and rejects your treatment request is not a doctor. Probably not even a college graduate.
Don't blame the government for the actions of the free market. The government is just trying to stop the blatant abuses.
Remove patent protection if companies cannot properly and adequately supply medication.
Most of these drugs were developed under US Government grants in research labs. They are not patented - they are licensed to drug manufacturers. The answer is to cancel their license and issue it to a competitor. Very few drugs are actually developed and patented by big pharma.
I am willing to bet the real problem is all the polluted and compromised ingredients the greedy pharmacorps insist on purchasing and then selling the American public.
Any risk is worth it as long as MegaCorps and the economic elite can make huge profits regardless the price Americans must pay.
Let Ron Paul wave his coins at that.
What's really sad is that these companies risk their own families and children.
Ill say it again this supposed shortage is NOT real. It is manufactured by drug companies to cause prices to rise to jack up profits. There is no shortage of the raw resources required to make drugs and thus there is no true shortage of drugs.
I'am a quality manager .I have been in the business for over 31 years and quality is getting very shoddy and unimportant all over. Since the economy has been tanking companies are using it as a cost saving platform. Although it is characteristically promoted and mentioned in all the dialogue, its getting to the point where your trust of a quality product is creating doubt. There will always be quality issues no matter what. But in the case of a inject able being contaminated with mold is very scary..... These contract vendors need some real scrutiny before they are ever considered as being a filler. I would rather have a quality issue like, a slightly faded label, or a dent in a plastic bottle......but a contaminated inject-able is absolutely zero tolerance. One more thing quality of U.S. manufactured items vs Asian....there is no comparison....stick with a U.S. item.
My question is this- WHY is there a drug shortage in the first place? If there is such a problem, wouldn't that make it much easier for companies in the US to start new drug manufacturing companies?
P.S. I'm part Republican, but I've always thought strict governmental oversight of this type of thing is good. Actually, I think strict governmental oversight of a LOT of things is good.
I think one of the problems is the level of intelligence of the workers, and the fact that many workers are pretty casual about safety and health regulations. For example, wearing rubber or vinyl gloves is excellent, but it doesn't do a whole lot of good if the worker wipes their nose or scratches their face with the glove on. Or if they grab the rubber/vinyl glove by the fingers before they put it on, rather than holding the gloves by the wrist and sliding the hand into the glove. Much contamination just in that one area. I'm thinking in the area of health care right now.