FDA Bans Product from Compounding Pharmacies, Then Hands Exclusive Rights to Single Pharma CompanyA safe and inexpensive drug used to prevent premature births, the FDA stopped compounding pharmacies from making and selling it. Then, they handed exclusive rights to a Big Pharma firm, which increased the price by 15,000 percent.by Heidi Stevenson24 March 2011 
Over the last few years, the FDA has been targeting compounding pharmacies, ordering them to stop producing many safe and inexpensive drugs and bioidentical hormones. The FDA's actions have seemed to be without cause. We now know, though, that there was a malevolent purpose behind these actions, the result of the loss of distinction between the FDA and the industry it's supposed to regulate, Big Pharma. Pregnenolone is a steroid hormone that the body naturally manufactures. It's a precursor to several other hormones, including DHEA, progesterone, testesterone, estrogens, and cortisol. Through decades of use, it is known to be safe and useful in a variety of concerns; the best known is prevention of premature births without adverse effects. Big Pharma had little interest in it because the profits were minimal. So, compounding pharmacies stepped into the gap; they prepared pregnenolone for doctors' prescriptions. The cost was about $10 per treatment. Over the last few years, the FDA has acted agressively to prevent compounding pharmacies from producing and selling pregnenolone. They claimed that it should be classified as a "new drug", in spite of its existence for decades. One had to wonder why the FDA stepped in. There were no claims of adverse effects, no claims that it wasn't doing what doctors prescribed it for. There were no problems associated iwth pregnenolone. Now, though, the mystery has been solved. After helping to keep pregnenolone off the market by preventing compounding pharmacies from formulating it, the FDA then declared it to be an orphan drug, which is defined as a drug that's potentially useful for a medical condition so rare that manufacturers aren't willing to test it because there aren't enough potential subjects to make it profitable. Of course, pregnenolone had already been developed and tested, not to mention having many decades of experience behind it. It was also inexpensive at about $10 per treatment. So, the FDA granted exclusive rights for pregnenolone to a single firm, KV Pharmaceutical. With that authorization in hand, KV then unleashed its own attack on the compounding pharmacies, issuing cease and desist letters to compounding pharmacists. And then, KV raised the price of pregnenolone to $1,500 per dose—a price increase of 15,000%. Whereas prevention of premature deliveries had been within the means of nearly all pregnant women, it suddenly became out of reach to most. There cannot be any doubt about who the FDA is beholden to. Big Pharma owns drug portion of the agency. Agribusiness owns the food portion, as is obvious with the appointment of Michael R. Taylor, an attorney who has made nearly his entire career as an employee of Monsanto, a contractor with Monsanto, or as a Monsanto plant inside the FDA. There is no longer any reasonable hope that the FDA can be reformed. As its actions in stopping the manufacturing and sale of pregnenolone by compounding pharmacies, and then in granting exclusive rights to a member of Big Pharma clearly demonstrate, the FDA is a rogue agency, acting for the benefit of those it's meant to regulate, and doing so at the health and financial expense of the people it's supposed to protect. ***************************************************************************** *****************************************************************************
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