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Compounding pharmacies -- heroes or outlaws?

A single compounding pharmacy, one that mixes up drugs to order, appears to be the source of contamination that has killed 12 people and made more than 100 sick with a rare form of fungal meningitis. Some consumer advocates want the Food and Drug Administration to crack down harder on such pharmacies, but the legal battle to regulate them has been long and convoluted.

The question is whether the New England Compounding Center, which made and sold the contaminated steroids blamed for the outbreak of rare fungal meningitis, is truly a legal compounding pharmacy, or an illegal drug manufacturer. NECC has voluntarily closed and recalled all of its drugs. Reuters reported on Wednesday that a second pharmacy, Ameridose LLC, which shares common ownership with NECC, plans to shut down voluntarily for a week as a precaution.

So-called compounding pharmacies are frequently at the center of controversy. They’ve been heroes to advocates of “bioidentical” hormones such as actress Suzanne Somers, who sells her own books, DVDs and blogs promoting the idea. Professional medical associations including the Endocrine Society and American College of Obstetricians and Gynecologists say these individually mixed hormone remedies are bogus.

“One of the big problems is that we just don't know what risks are associated with these so-called 'bio-identicals’,” said the FDA’s Steve Silverman

The pharmacies were also folk heroes for a while in a battle over a drug that prevents preterm births. It’s a synthetic form of the hormone progesterone called hydroxyprogesterone caproate. Compounding pharmacists can make it for just a few dollars a dose, or about $400 per pregnancy. Then KV Pharmaceutical of St. Louis came up with an FDA-approved version last year and priced it at $1,500 a dose – dropping that to $690 a dose after a prolonged outcry, but still nearly $14,000 to preserve a pregnancy to term.

The FDA sat on the fence for a while, but eventually chased down some pharmacies making compounded versions. “We are writing to ensure that Wedgewood Pharmacy is not operating under the misimpression that there is a ‘green light’ to compound large volumes of copies of Makena,” FDA told the president of one New Jersey compounding pharmacy last June. FDA said its main concern is that the products sold aren’t contaminated, and that they actually work safely.

Compounding pharmacies can also step in when there’s a shortage of a vital drug.

Under the FDA’s definition, compounding pharmacists are supposed to mix drugs to order only on an individual basis in response to a prescription from a doctor. For instance, if a child is allergic to one of the inactive ingredients in a pill, or if a medicine tastes bad, a compounding pharmacist can remix the product to make it safe or palatable.

Under this definition, the New England Compounding Center was not operating as the FDA prescribes. State pharmacy boards are supposed to regulate this activity but the FDA can step in when there’s contamination, as in this case, or when the agency believes pharmacies are breaking the legal limits.

The consumer group Public Citizen says FDA failed this time. “The large-scale production of a drug -- in this case, a drug that is intended to be sterile and injected into patients -- appears to have crossed the line from the traditionally narrow role filled by local compounding pharmacies into one that clearly involves drug manufacturing and the release of products into interstate commerce,” Dr. Michael Carome, Deputy Director of Public Citizen’s Health Research Group, says in a statement. NECC’s  products, now recalled, were distributed to pain clinics in at least 23 states.

"However, the FDA failed to take action to ensure that the New England Compounding Center adhered to these drug standards, which are essential for protecting the health of patients.”

Members of Congress are paying attention, too. Reps. Ed  Markey, a Massachusetts Democrat, and Rosa DeLauro, a Connecticut Democrat, say they intend to introduce legislation that would more closely regulate these pharmacies. They can’t do anything without Republican support – the House is controlled by Republicans – but the Republican-led Energy and Commerce Committee says it will call in the FDA and the Centers for Disease Control and Prevention for a hearing this week. 

“These compounding pharmacies are operating as factories, mass-producing and packaging specialized new drugs in large quantities and then sending them over state lines,” Markey says. “These compounding pharmacies are compounding risk -producing complex drugs in bulk and then distributing them across the country. Unfortunately, compounding pharmacies are a 19th century service operating in a 21st century industry, and we need to update and strengthen the rules that govern these operations so that patients can safely benefit from the unique service they offer.”

Congress tried to strengthen FDA oversight of compounding pharmacies in 1997, but the law fell apart under challenge.  It prohibited the pharmacies from advertising, something that the Supreme Court ruled was unconstitutional. Jonathan Berman of the law firm Jones, Day says the status of the remainder of the law is unclear now. “Nobody knows whether that law is valid or not,” Berman said in a telephone interview.

He thinks the Supreme Court could and would make a ruling – if someone would bring an appropriate case. "The question is whether there will be another case that presents the same issue.  The government hasn't brought many cases against compounding pharmacies," Berman said.

Despite the absence of clear rules, Berman says, some compounding pharmacies have grown much larger. "More and more these days you see pharmacies trying to fill a niche by compounding large quantities,” he said. They should have a lawful way of doing business, because what they do is important.”

While the NECC could argue that it was filling a shortage, the FDA denies it. The drug doctors believe was to blame is called methylprednisolone, a steroid injected into the back for pain.  “There are FDA approved versions of methylprednisolone acetate injection on the market, available with or without preservatives,” the FDA says in a statement. “FDA’s drug shortage office has confirmed that NECC’s voluntary shutdown will not affect the nationwide supply of methylprednisolone acetate.”

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