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Republican Senator Urges Tighter Regulation On Pharmaceutical Facilities

By Sy Mukherjee on July 3, 2013 at 12:45 pm

"Republican Senator Urges Tighter Regulation On Pharmaceutical Facilities"

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On Tuesday, Sen. Lamar Alexander (R-TN) urged the full U.S. Senate to take up a bill granting the U.S. Food and Drug Administration (FDA) more regulatory authority over nontraditional compounding pharmacies — facilities where large amounts of custom drug batches are mixed and prepared — as the death toll from last year’s deadly meningitis outbreak linked to such a facility has risen to 61. Republicans in the House of Representatives have been holding back reform efforts despite widespread consensus on the issue in the Senate.

“Americans continue to lose loved ones from the meningitis outbreak, and the Commissioner of the Food and Drug Administration has warned us that this will happen again if Congress fails to act,” Alexander said, echoing warnings from FDA director Margaret Hamburg that the agency’s inability to regulate so-called compounders leaves it unprepared to cope with a future crisis.

Although the Senate’s main health committee passed legislation granting the FDA’s request for more oversight power — including the establishment of a federal database of compounders — it still hasn’t come up for a full vote in the Senate. Even if the bill eventually passes, reformers might come across a road block in the form of House Republicans, who have questioned giving the FDA more power considering its failure to prevent the meningitis outbreak. “Ten years of warning signs, alarm bells and flashing red lights were deliberately ignored. Ultimately, the FDA knew [the compounding facility] was breaking the law but chose to do nothing,” said the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigation chairman Rep. Tom Murphy (R-PA) during a hearing in April.

Public health officials — and lawmakers from both parties in the Senate — dispute that logic, arguing that a lack of funding and clear lines of authority between the FDA and states are actually to blame for the failure.

After the meningitis outbreak, the FDA launched a comprehensive investigation into 18 states’ compounding pharmacies. They found unsafe practices at almost every facility that it audited, including the presence of mold in mixing labs. But without congressional action, the agency has been powerless to follow through on those findings or compel the pharmacies to change their practices, leaving states to take the lead in ramping up regulations on compounders.

Still, states claim they still need help from Congress, since their budgets aren’t large enough to fund all the necessary regulations and inspections. “It’s partly a matter of resources,” said Joseph Hill, legislative director for the American Society of Health-System Pharmacists, in a May interview with Politico. “You can have the perfect regulation, but if you can’t spend the time and money to give your people specialized training and send them to do inspections, the regulation won’t matter much.”

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