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POLITICS

Are regulations on drug-manufacturing just protectionism for Big Pharma?

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Politics,Beltway Confidential,Timothy P. Carney

When restaurants lobby for “consumer protection” regulations that restrict food trucks, it’s natural to suspect the restaurants are simply trying to use Big Government to crowd out competition.

When H&R Block lobbies for “consumer protection” regulations that crowd out Mom & Pop tax preparers, the anticompetitive.

When liquor stores lobby to keep supermarkets from selling liquor, we don’t assume their main motive is consumer protection.

This month we see the same dynamic in the drugmaking industry, the Washington Post reports:

Drug companies are ramping up efforts on Capitol Hill to block specialty pharmacies from mass producing drugs in lightly regulated conditions, urging lawmakers to require that these enterprises return to their traditional roles or face stricter standards.

Commercial drug makers are also pressing a lobbying campaign aimed at stopping these specialty pharmacies, known as compounders, from making “knockoff” drugs for people and their pets that the companies say are costing them millions of dollars in annual profits, records and interviews show.

But the lobbying landscape gets even more interesting, as the Post reports:

The International Academy of Compounding Pharmacists, the industry’s largest trade group, is asking for federal and state legislation that would require compounders to adhere to guidelines that are currently voluntary. The guidelines run more than 400 pages long and were developed by pharmacists, doctors and nurses.

“We believe they need to be mandated by law,” said David G. Miller, IACP’s executive vice president.

Miller said he told congressional staffers that he still wants state inspectors to retain the authority to enforce the standards for most compounding pharmacists. Last month, Miller reversed course on his long-held position that all compounders should be regulated by state boards of pharmacy, saying manufacturing-style firms that market and sell products without patient-specific prescriptions should register with the FDA and be inspected by the agency.

The shift in IACP’s position followed a Washington Post investigation that showed 15 of the nation’s largest compounding pharmacies mass produce medications, often shipping them across state lines without patient prescriptions. The Post also reported that shoddy equipment and unsanitary conditions at some of these firms had caused patient illnesses and deaths long before this fall’s deadly outbreak but that the firms rarely were penalized.

 

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