“By clarifying FDA authority over high-risk compounding practices, this bill will enhance protections for patients taking compounded drugs and help prevent crises like last year’s tragic meningitis outbreak,” Harkin wrote in support of the proposal.
Last fall, the New England Compounding Center (NECC) was blamed for an outbreak of meningitis bacteria. To date, at least 50 people have died and more than 700 have contracted the painful disease because of the NECC contamination.
The entities, which are supposed to make medications in small or individual batches, often fall outside of federal oversight.
Alexander said he wanted to eliminate any uncertainty as to who has power over these facilities.
“Our goal with this bill is to put an end to FDA inaction and make it clear who is on the flagpole — who is in charge and accountable for oversight of these pharmacies and manufacturers," the Tennessee lawmaker said.
The FDA has expressed frustration and confusion with existing laws and regulations.
The proposal will require compound manufacturers — which create larger lots of drugs than compounders that respond to individual prescriptions — to register with the FDA and talk about the products they make, how they make it and various other oversight reporting measures.
It would set concrete terms, the senators said, for what types of drugs can be produced in bulk, and would even extend the new rules to entities that produce drugs for animals.
Lawmakers also want to impose an annual “establishment fee” to offset the costs associated with inspections.
“When drugs are prescribed to make a patient healthier — and in many cases, save a life — that patient should know their prescription is exactly what the doctor ordered,” Franken said in a statement. “We've seen far too many deaths in this country because some pharmacies have acted more like drug manufacturers — without following rigorous safety rules.”
Last year, Democrats in Congress introduced a few bills trying to impose stricter rules on compound pharmacies, none of which gained much traction.
Republican supporters noted the balance the draft bill strikes between the industry and patients.
“This legislation was very carefully crafted as an attempt to address concerns from stakeholders and patients,” said Roberts in a written statement. “We owe it to victims and the American people to get this right.”
A trade group for small pharmacies said in January that they rejected any need for increased regulation.
“As a country, we must strike the right balance to go after rogue entities like NECC while preserving patients’ access to the safe and essential compounded medications that their physicians prescribe,” said B. Douglas Hoey, the chief executive of the National Community Pharmacists Association. “NECC was in fact evading necessary regulation in part by purporting to be a compounding pharmacy.”