Wednesday, August 14, 2013

Rumor Mill: FDA issuing 483 Letters in Effort to Support S.959

The rumor mill is a buzz with claims from sterile compounders across the country that the FDA is making sweeping inspections to build a case to support their power grab for control of the compounding space through Senate Bill 959.

The FDA is claiming that pharmacies that engage in large-scale drug compounding, produce drugs in anticipation of individual prescriptions or without prescriptions, and sell them across state lines, are engaged in drug manufacturing, therefore, are under FDA purview. However, authority of the FDA to oversee drug compounding is unclear.

The circuit split regarding whether only part or the entirety of Section 503A of the Food and Drug Administration Modernization Act (FDAMA) is invalid. In Thompson v. Western States Medical Center, the U.S. Supreme Court determined that the advertising provisions of Section 503A were a violation of compounding pharmacies' First Amendment rights and were therefore unconstitutional. The Supreme Court did not decide on whether the remaining parts of Section 503A, which discussed FDA's authority over compounding pharmacies, were still valid. The Ninth Circuit has ruled that the entirety of Section 503A is invalid, while the Fifth Circuit ruled that only the advertising provisions are invalid.

That hasn't stopped the FDA from interrupting business of many compounders and holding multi-week inspections, claiming that they now have oversight. More interesting, the FDA is now holding compounding pharmacies to cGMP, knowing that no compounders are held to that standard. Most, if not all, compounders are held to USP 797 and other standards such as PCAB.

What remains unclear, and even more alarming, is the percentage of the drug shortage market that compounders are now making up. While estimates vary, some industry experts think the number could be as high $300mln a year. The implications for the drug shortage market could be disastrous if the FDA were to shut down the entire industry. While Senator Harkin and the FDA have the American people in mind, the law of unintended consequences could be monumental in this instance.

According to, the bill only has a 28% chance of passing in its current form. That said, given the FDA's scare tactics, many sterile compounding pharmacies are shirting gears toward non-sterile products such as HRTs and Vet Meds. If a large percentage of sterile compounding pharmacies choose to get out the business because of the unclear legal risk, s959 might not even need to pass to make the nations drug shortage crisis exponentially worse.

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