Although more than half of the estimated 56,000 U.S. pharmacies across the country practice compounding — repackaging or recombining medications on a large scale, in an attempt to keep down the costs of filling prescriptions — the FDA cannot oversee this sector of the pharmaceutical industry. The FDA has authority over drug manufacturers, not pharmacies, so drugs that are compounded at pharmacies do not currently have to meet the agency’s guidelines to ensure they are safe or effective.
In order to mitigate potential public health risks stemming from compounded drugs, Democratic lawmakers and health advocates are calling on Congress to strengthen FDA’s regulatory oversight in the area:
“These compounding pharmacies are operating now on a scale where (regulation) should be a priority,” said Senator Richard Blumenthal, a member of the Senate Health, Education, Labor and Pensions Committee, who is urging hearings and an investigation in prelude to new legislation.
His concerns were echoed by U.S. Representative Edward Markey, another Democrat who sent a letter to the FDA asking whether agency rules ensure that compounded drugs meet the same safety standards as the products of major drug manufacturers. [...]
Disease outbreaks have been traced to compounding pharmacies repeatedly in the last decade, including other cases of meningitis and hepatitis C infections.
“If regulation doesn’t set a standard that seeks to prevent this, we can expect these outbreaks to keep happening,” said Dr. John Santa, director of the Health Ratings Center at the Consumers Union advocacy group.
Seventy five health facilities received the potentially contaminated steroid injections from the New England Compounding Center between July and September. The Massachusetts-area compounding pharmacy voluntarily recalled all of its products over the weekend following the FDA’s recommendations.
And the larger clash between the pharmaceutical industry’s interests and the FDA’s public health regulations could eventually make its way to the Supreme Court. Although repeated legal challenges have attempted to slowly chip away at the FDA’s authority over pharmacies practicing compounding, an appellate court in New Orleans sided with the FDA in 2008. But if a current case against the FDA that is set to be decided in Florida goes the other way, the Supreme Court could step in to arbitrate.