Obamacare debate snags pharmacy bill
A year after a meningitis outbreak from contaminated pain injections killed at least 64 people and sickened hundreds, Congress is ready to increase federal oversight over compounding pharmacies that custom-mix medications.
Before the bill gets to President Obama for his signature, it first has to clear a hurdle put in its path by Sen. David Vitter, Louisiana Republican, in his ongoing campaign to discredit the president’s health care overhaul. A test vote is scheduled for Tuesday evening.
The legislation, passed by the House in September, also creates a national system for tracking prescription drugs from manufacturers to retail pharmacies, first through serial numbers on bottles and containers and later through electronic codes.
Although the bill enjoys nearly universal support in Congress, Mr. Vitter has objected to the Senate voting on it without first voting on his measure to make members of Congress disclose which of their aides are signing up for the health care law, and which are instead being allowed to remain in the Federal Employee Benefit Program.
Mr. Vitter objects to an Obama administration decision earlier this year allowing lawmakers to choose between the two programs for their aides, and directing the government to pick up three-fourths of the premium costs for members of Congress and their aides either way. Lawmakers themselves have to switch to coverage under the health care law. Mr. Vitter’s insistence on ending the employer match earlier this year prompted Senate Democrats to scuttle an energy bill. The issue arose again in last month’s showdown over the government shutdown.
The compounding pharmacy bill is intended to avert a repeat of last year’s meningitis outbreak associated with the now-closed New England Compounding Center. Subsequent inspections found unsanitary conditions at the company’s plant in Framingham, Mass., including mold and standing water.
Contamination problems with compounded medicines have been reported for decades. But jurisdiction over them has been murky. Pharmacies are typically regulated through state boards, but the Food and Drug Administration regulates manufacturers of medicines.
The bill attempts to sort out that legal gray area which allowed the NECC and other pharmacies to skirt both state and federal regulations. The measure clarifies the FDA’s authority to shut down pharmacies that become so large they resemble manufacturers, but it doesn’t require those pharmacies to register with the agency, a step that would have subjected them higher quality standards and inspections. Instead, pharmacies can volunteer to be regulated by the FDA as a sort of optional “stamp of approval.”
Still, public safety advocates who lobbied for the bill say it improves the status quo.