Individualized and natural medications are under threat. Action Alert!
Millions of Americans rely on customized medicines made at compounding pharmacies, including bioidentical hormones like estriol. That access is threatened by an FDA advisory committee that is rife with conflicts of interest, including the pharmaceutical industry, which competes with compounding pharmacies.
For years now, we’ve been reporting on the FDA’s Pharmacy Compounding Advisory Committee (PCAC). The committee plays an important role in advising the FDA on implementation of the Drug Quality and Security Act of 2013 (DQSA). Thus far PCAC’s main role has been to make recommendations regarding which substances should or should not be included on the Bulk Drug List as well as the Difficult to Compound list. When completed, these lists will dictate which medicines can continue to be made at compounding pharmacies—specialized pharmacies that make customized, oftentimes natural medications to meet the needs of individual patients.
Unfortunately, the track record so far has been abysmal, with PCAC routinely following the FDA’s lead and voting to exclude almost every natural medicine with which they’re presented.
A big part of the problem is PCAC’s composition. As we’ve pointed out before, the committee is a stacked deck against pharmacy compounding. Only one member of the committee is a compounder, and he cannot vote. Of the remaining eleven PCAC members, four are academics, three are government officials (one from FDA and two from the National Institutes of Health), and three are non-profit representatives.
Of particular concern is Pew Charitable Trusts’ representation on the committee. Pew presents itself as “an independent, nonpartisan research and public policy organization with a longstanding focus on drug quality issues, including pharmaceutical compounding.” Upon closer examination, though, it seems to us that Pew isn’t so “independent” and may have aligned itself with the pharmaceutical industry.
On June 12, 2017, Pew signed a letter with PhRMA, the trade association for the drug industry, directed to the House Appropriations Committee Chairs and Ranking Members. The letter advocated positions that would financially benefit drug companies, encouraging tighter regulation of compounding pharmacies—which of course make medicines that compete with pharmaceutical drugs.
Then, in September 2017, Pew sponsored a congressional briefing in partnership with Biotechnology Innovation Organization (BIO), another trade group boasting the biggest names in the pharmaceutical industry. Once again the message was to restrict consumer access to compounded medications, a position that would financially benefit members of BIO.
Pew holds a voting seat on PCAC, but we believe it has a conflict of interest as it partners with pharmaceutical interests on public facing efforts to restrict patient access to compounded medications. Two members of PCAC represent the pharmaceutical industry and compounding pharmacy. Both are non-voting members, in order to mitigate potential conflicts of interest. We don’t believe Pew should hold a voting position on PCAC when it advocates in partnership with pharmaceutical companies and takes positions that could greatly benefit these private entities.
PCAC should be comprised of voting members with an expertise on compounding who can form objective opinions. The rules governing the compounding industry, which is so crucial to millions of Americans, should not be set by competing companies—and their allies—who would benefit if the industry was regulated out of existence. We believe Pew should be replaced with an organization that can fulfill this important function.
Action Alert! Write to the FDA and Congress, telling them that Pew must be removed from PCAC due to conflicts of interest. Please send your message immediately.
