Meningitis outbreak: 119 cases, 11 deaths so far.

Blame rightwing ideology of States rights, deregulation & greed for no FDA Oversight.

online.wsj.com

…snip…

If the FDA had full oversight of these pharmacies, it could treat their compounds as new drugs and require the pharmacies to submit clinical trials before the drugs are allowed on the market. It also would have more powers to inspect facilities.

There are about 3,000 compounding pharmacies, and drugs made by the facilities represent as much as 3% of the roughly $300 billion in prescription drugs sold in the U.S. each year, according to the International Academy of Compounding Pharmacists, an industry group.

The FDA has pushed in recent years to increase its regulatory authority over compounding pharmacies. But it has been stymied by, among other factors, a 2002 Supreme Court decision. In the majority opinion, written by Justice Sandra Day O’Connor, the court struck down as unconstitutional the portion of a 1997 law setting out how the FDA would decide which compounding pharmacies it would regulate. The FDA had pushed for the 1997 legislation, according to agency officials.

The FDA issued a 2007 warning noting that compounded drugs “are not FDA-approved.” It said there had been “devastating repercussions” from such drugs, included three patients dying of infections from a drug used to paralyze the heart during surgery and two patients at a veterans hospital who were blinded by a compounded product used in cataract surgery.

Another piece of guidance from the FDA said it “should seriously consider enforcement action” if the “nature and scope” of a pharmacy’s activities are more like a drug manufacturer than a drugstore. But it hasn’t gone back to Congress to codify its regulatory standards and has supervised compounding pharmacies only fitfully, current and former agency officials said. The FDA declined to comment.

“This method of taking enforcement cases from time to time hasn’t really worked,” said Mary Pendergast, a former FDA lawyer.

The compounding pharmacy industry has created safety standards meant to reduce the risk of tainted products. In 2004, United States Pharmacopeia, an industry-backed nonprofit, established safe-practice guidelines for compounding pharmacies.

But the industry is required only in 17 states to follow the guidelines, according to a survey conducted this year by Pharmacy Purchasing & Products, a trade publication. Researchers found that compounding pharmacies in states that required the guidelines reported higher levels of compliance.

“This is yet another preventable event that’s harmed way too many people,” said Eric Kastango, one of the researchers from the PP&P survey who also helps update the guidelines.

Part of the struggles with maintaining oversight of the compounding-pharmacy industry is that there are few avenues for quality control of the product—except when tainted products sicken or kill people, health officials and pharmacy experts said.

There are no legal requirements that compounding pharmacies test each batch of injectable steroids or record where they go, said Carmen Catizone, executive director of the National Association of Boards of Pharmacy. “It’s something the good pharmacies do and the other pharmacies don’t,” he said.

States cite several reasons why they don’t require compounding pharmacies to adhere to the industry-created guidelines. The higher costs and the need to conduct more frequent monitoring and sampling of the work areas are the most commonly cited reasons by compounding pharmacies for not complying, said Kate Douglass, president of Performance Strategies LLC, which consults sterile compounding pharmacies on safety issues.

——>Continued