Compounding pharmacies have long evaded the tight oversight governing established drug makers
Mass. congressman seeks tougher rules for compounders
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Compounding pharmacies have also been a concern to pharmaceutical giants that consider them competition, sometimes undercutting their brand-name products by offering cut-rate prices on the same remedies.
FDA officials issued guidelines in 1992, putting compounding pharmacies on notice that regulators could “initiate enforcement actions . . . when the scope and nature of a pharmacy’s activity raises the kinds of concerns normally associated with a manufacturer and that results in significant violations of the [FDA’s] new drug, adulteration, or misbranding provisions.” The guidelines said the agency would defer to state boards on regulation of smaller “traditional” compounding.
The policy set the stage for the FDA Modernization Act, passed by Congress in 1997, which gave the agency more power to treat compounding pharmacies like other drug makers. The law was passed over the objections of the industry’s main lobbying group.
Over the past decade, the association has spent $1.1 million on federal lobbying — a minuscule amount compared with the $153.1 million spent last year alone by the pharmaceutical manufacturing industry.
The compounding pharmacies organization has given $201,324 to candidates from both parties during the current election cycle, according to federal data compiled by the Sunlight Foundation. Representative Charlie Bass, a New Hampshire Republican, got $10,000 from the trade group. It also donated $6,000 each to Senator Orrin Hatch, a Republican from Utah, and Senator Sherrod Brown, a Democrat from Ohio.
This month, Senator Scott Brown said he would donate $10,000 to the Meningitis Foundation of America, the same amount the Massachusetts Republican got from the owners and executives of the New England Compounding Center.
After a group of compounding pharmacies filed a lawsuit challenging the 1997 law, the US Supreme Court in 2002 struck down a portion of the law limiting advertising by compounding pharmacies, ruling it violated the right to free speech. That decision was later interpreted in some lower courts as stripping away the FDA’s ability to regulate the compounding industry.
While the FDA continued to oversee compounding pharmacies under its compliance policy guidelines — by, among other things, sending warning letters that in some cases led to pharmacies being shut down — the lobbying group redoubled efforts to fend off more stringent regulation. Most notably, it foiled attempts in Congress, including the one by Kennedy and other lawmakers in 2007, to give the FDA broader authority to inspect facilities and control the sale of compounded drugs.
“Clearly, the industry and trade groups would like less oversight and less regulation and have lobbied for that over the past 10 years,” said Dr. Michael Carome, deputy director of health research for Public Citizen, a consumer advocacy group that has long been concerned about the industry.
Carome faulted the FDA for not doing more, using the agency’s existing authority.
“We’re not saying there is no need for further regulation,” he said, “but our fundamental position is that current laws give the FDA more than enough authority to have prevented this outbreak of fungal meningitis.”
Before the meningitis crisis, the compounding industry had been attempting to raise its profile by running commercials on airport televisions. After the news about the infections, the International Academy of Compounding Pharmacists hired a Newton public relations firm to field questions about compounding companies.
“For too long, compounding pharmacies have been governed by fragmented regulations and inconsistent oversight,” said Markey, the senior Democrat on the House Energy and Commerce Committee, which has jurisdiction over the FDA. “This tragedy now demands the strongest response from Congress and federal and state authorities.”