Critics: Obama shares outbreak blame
Drug rules loosened on his watch
By Chris Cassidy and Erin Smith
Wednesday, October 10, 2012 -
Under the Obama administration, the FDA has opted not to crack down on compounding pharmacies that are mass-producing cheaper drugs under less scrutiny than heavily regulated pharmaceuticals as part of a push to reduce health costs, a former top Bush-era FDA official told the Herald.
“The administration made the decision that having access to cheap drugs is more important than the assurances of safety and efficacy from the FDA,” said Sheldon Bradshaw, the FDA’s senior legal counsel in the George W. Bush administration who now works as a Washington lawyer representing corporations regulated by the FDA.
The practices of one compounding pharmacy, Framingham-based New England Compounding Center, are now under federal and state investigation after the company’s steroid injections for back pain were linked to the nationwide fungal meningitis outbreak that reportedly has sickened 119 and killed 11 people.
Bradshaw said the administration’s demand for cheap drugs was reflected in the FDA’s decision in 2011 not to go after cheaper compounded versions of the premature birth prevention drug Makena, manufactured by KV Pharmaceuticals, which subsequently sued the FDA and lost.
“That act has emboldened pharmacy compounders and as a direct result, pharmacy compounders for the last year and a half have thought they could compound with impunity copies of FDA-approved drug products,” Bradshaw said.
Boston University law professor Kevin Outterson noted compounding pharmacies were relieved of some regulation in 2002, when the U.S. Supreme Court struck down a law regulating them because of a provision that banned them from advertising. Outterson said Congress failed to amend the law.
“It could have been fixed a decade ago,” Outterson said.
U.S. Rep. Edward J. Markey yesterday said he intends to address the oversight issues surrounding compounding pharmacies.
“It is a regulatory black hole,” Markey told the Herald. “I think it is shocking the magnitude of the sales by one company across the United States without FDA regulation — 17,000 across various states. That’s impossible for an individual state to regulate.”
FDA spokeswoman Erica Jefferson said the agency tries to ensure drugs are “high-quality, safe and effective.”
“When the Agency becomes aware of potentially contaminated or otherwise adulterated or misbranded compounded drug products, FDA investigates and works with its state counterparts to take appropriate action as quickly as possible,” she said, though she noted states have “primary jurisdiction over compounding pharmacies.”
The Massachusetts Department of Public Health said its Board of Registration in Pharmacy only inspects facilities upon initial licensure, relocation or in response to complaints.
Outterson said state regulation will do little to fix the problem. Even if Massachusetts had strict rules in place, compounding companies could just move to more lenient states, while their products could still be shipped across the country.
“For states to try to regulate this is really difficult. It has to be done nationally,” said Outterson.
Christine McConville contributed to this report.
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