Last October, a tainted batch of steroids created at a New England compounding pharmacy — a facility where large batches of drugs are mixed and prepared for use in custom medication — infected hundreds of Americans and killed 64 of them from bacterial meningitis. Lax federal oversight and blurred lines of authority over compounders was largely blamed for the outbreak. Now, a bipartisan group of lawmakers want to make sure that such a public health disaster doesn’t happen again.
Reps. Morgan Griffith (R-VA), Gene Green (D-TX), and Diana DeGette (D-CO) have introduced H.R. 3089, a bill that would establish Food and Drug Administration (FDA) oversight of large compounders that ship their products across state lines. While state pharmacy boards would still have the primary responsibility for regulating such facilities, compounders that outsource their products would have to register with the FDA, report the drugs they make, be subject to federal inspections, and clearly label their medications.
“For the last several weeks, a bipartisan and bicameral group of lawmakers have been meeting to make sure we never relive the tragedy of the 2012 fungal meningitis outbreak that originated in a compounding pharmacy in Massachusetts,” said Green in a statement announcing the bill.
The Senate’s main health committee passed similar legislation in May — but progress has been slow since then, spurring Republicans and Democrats alike to stress the importance of overseeing the largely-unregulated compounding pharmacy industry.
“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,” said Sen. Lamar Alexander (R-TN) in July.
Some members of the House GOP have been holding back reform. Many have expressed skepticism about the FDA’s need for more authority and regulatory powers over compounders — even though FDA inspections conducted after the meningitis outbreak revealed rust, mold, and other unsanitary conditions in the many facilities in 18 states.