Is there are rhyme or reason to the FDA’s approach to safety?
On food dyes and ADHD there was no reason to revisit an issue that channels the same approach to causality the Andrew Wakefield, Jenny McCarthy and anti-vax crazies used. (And shame on the media for not referring to the European Food Safety Agency report trashing the Lancet article most reporters cited – in tandem with a real life story of a kid being cured of ADHD by going natural. As in: “In 2009, EFSA re-evaluated the safety of the six color additives used in the Southampton study and concluded that the available scientific evidence does not substantiate a link between the color additives and behavioral effects.)
Are reporters that biased or lazy that they can’t get beyond the he-said/she-said approach to reporting.
In any event, why, with this knowledge in hand did the FDA grant Center for Science in the Public Interest’s ( the same group that sued McDonald’s for offering Happy Meals to kids) citizen petition which was submitted in 2008?
Now the FDA has decided to allow pharmacists to compound a drug (Makema) developed by KV Pharmaceutical that significantly reduced the risk of certain preterm births in women who have had at least 1 prior preterm birth. Previously, the agent had only been available from pharmacies that had compounded the drug.” The FDA and ob-gyns had wanted a version of the injectable product that meet specific safety and efficacy standards. Since “Makena is a sterile injectable with a risk of contamination, greater assurance of safety is provided by an approved product. “
http://www.modernmedicine.com/modernmedicine/Clinical+News/FDA-wont-take-action-against-pharmacies-that-compo/ArticleStandard/Article/detail/714333?contextCategoryId=40157
After developing an FDA approved version of a drug that was in danger of becoming obsolete, KV promptly – and without warning – decided to charge $1500 for each dose. The company was rightly criticized for the sudden jump in price and did the right thing by cutting the retail price of the drug to $680 and offering the drug for free for a Medicaid price to a wide range of organizations.
The FDA decided to allow pharmacists to continue compounding even though KV developed the drug to put an end to the risk associated with compounding products. In case anyone didn’t know, the FDA is currently Investigating “bacteria that sickened 19 people at Alabama hospitals and may have killed nine and has turned up at compounding pharmacy in Alabama.
And then there were the pre-filled syringes of heparin and contaminiated compounded CF drugs.There are many more such examples.
To be sure the FDA does have the authority to ensure the availability of products and indirectly considers affordability. It did so when it kept generic asthma inhalers on the market for several years rather than forcing them off to comply with an EPA requirement to remove inhalers powered by CFCs.
But that was a well-considered and organized action. This is a reaction to the media hype. Indeed, the FDA even got involved in a little demagoguery when it cited the fact that the NIH had provided KV with support to conduct clinical trials as the reason to allow the compounding they sought to eliminate. Give that logic, maybe every drug developed in cooperation with the NIH or based on NIH research should be compounded. How about a nice home made batch of Herceptin or HIV drugs such as Prestiva and Norvir?
All of this is preceded by the FDA’s children’s cough medicine obsession, you know that deadly drug that is linked to 39 deaths over 20 years, most of them do to overdosing by parents?
The FDA is in a shambles because of it’s pursuit of a politically correct position instead of a science-based regulatory policy. It's already discourage the makers of cancer drugs from pursuing follow studies by shifting the Avastin endpoint to overall survival. Now, its piling on KV and permiting the type of compounding that KV's drug was supposed to eliminate in an effort to protect expectant mothers. This is the Precautionary Principle run amok.
