Usually, the International Academy of Compounding Pharmacists, an advocacy group tied to the compounding industry, spends about $80,000 a year on lobbying. Not this year. In the first 6 months, it shelled out nearly $440,000 on lobbyists as it finds itself squaring off against pharma over how stringently the compounding industry should be regulated.
With bills to bring compounders under some level of FDA oversight making their way through both the House and Senate, Politico reports that legions of lobbyists are lining up to make their respective points. Groups like the Generic Pharmaceutical Association (GPhA) want compounders to have to meet the same standards its members do when manufacturing copies of their FDA-approved drugs. Compounders, well, they just want to be left alone by federal regulators.
Citing a survey that showed 40% of compounders would stop making some drugs rather than submit to federal oversight, the owner of one compounding company said patients would be the ones to suffer. "Pharmacists don't want to see the FDA engaged or involved with the regulation of pharmacies," Jim Smith, president of the Professional Compounding Centers of America, tells Politico.
But the way some traditional drugmakers see it, last year's fatal fungal meningitis outbreak tied to the New England Compounding Center shows that patients are not only suffering from lack of oversight of large compounders, they are dying from it. "The current debate has increased awareness of some of the dangerous practices that compounding facilities like NECC have been conducting for years without appropriate federal oversight," Auxilium Pharmaceuticals spokeswoman Nichol Ochsner told Politico. The company is a member of the Working Group on Pharmaceutical Safety, a new association of pharma companies established just to advocate for oversight of compounders.
Another member is KV Pharmaceutical, which went through bankruptcy reorganization last year, in part because the FDA would not prevent compounders from making copies of its premature birth drug Makena. The St. Louis-area company says its sells the drug for an average price of $690 a dose before rebates. (For those with insurance, the company says the average co-pay is $10.) A compounded version may go for $10 a dose. Sales of Makena have rebounded now that doctors are having second thoughts about using compounders for some complex drugs. KV spokeswoman Audrey Wu told Politico, "the practice of traditional drug compounding has evolved to a large-scale industry of drug manufacturing without FDA evaluation for efficacy, safety and manufacturing quality."
The FDA has been cracking down since the NECC debacle which sickened hundreds and killed dozens of patients. It has been inspecting the largest drug compounders, issuing warning letters to those with unsterile work areas and even seeking injunctions against those it considers the worst offenders. States traditionally inspect compounders, but since the NECC problems, the heat is on Congress to bring at least some of them under federal oversight. FDA Commissioner Margaret Hamburg has insisted that Congress needs to explicitly spell out what kind of hammer the agency can wield when it comes to compounding pharmacies. How big a hammer the FDA gets may very well depend on how much lobbyists spend with Congress to determine its size.
- read the Politico report