The House has not drafted a bill, but a House subcommittee will hold a hearing Thursday about state and federal laws governing the specialized pharmacies.
The Senate bill would establish a new category of FDA oversight that would apply to a part of the industry that has grown rapidly over the past two decades, from small corner pharmacies into businesses that operate like large-scale drug manufacturers. Many of these pharmacies, known as compounders, make a wide array of sterile medications, including antibiotics and painkillers, and ship them across state lines. Unlike traditional compounding pharmacies that custom-mix medication for individual patients based on prescriptions, these compounders often ship drugs without a prescription.
These products, unlike drugs made by major pharmaceutical manufacturers, are not FDA-approved. And the enterprises do not face the same level of scrutiny from the FDA that traditional drugmakers do.
Under the Senate bill, companies that make sterile products without or in advance of a prescription and sell those products across state lines would be required to register with the FDA and be subject to regular inspections.
Some consumer groups say the category is too narrowly defined. Only companies that meet all the criteria would be covered. Excluded would be large compounding pharmacies that sell defective or life-threatening oral drugs, topical creams and gels, said Nasima Hossain with the U.S. Public Interest Research Group, a consumer advocacy organization.
A compounder that sells in only one state would also be exempt. In addition, “anything in pill form wouldn’t qualify, and many chemotherapy drugs are in pill form,” said Diana Zuckerman, president of the Cancer Treatment and Prevention Fund.
Public Citizen, a consumer advocacy group, has opposed the creation of a separate category of FDA oversight for large-scale compounding pharmacies. It says it would be better to require the companies to follow the safety requirements that apply to commercial drug manufacturers.
The FDA has sought greater oversight of certain types of compounding pharmacies since the fall outbreak. But in a statement, the FDA said it was concerned that certain aspects of the Senate bill would limit the agency’s enforcement ability.
“Unfortunately, the proposed bill does not yet provide the clarity necessary to appropriately oversee this industry and may limit FDA’s ability to effectively protect the public health,” the statement said.
One small wording change in the bill that passed the Senate panel could weaken the FDA’s authority, industry experts said. It says traditional compounding pharmacies are to be defined “pursuant to state law.”
State laws vary, so a company that might be considered a drug manufacturer in one state could be defined as a traditional compounding pharmacy in another and be regulated differently depending on state law.
Allan Coukell, an expert on drugs at the Pew Charitable Trusts, said Pew supports the Senate approach even though it has limitations. “We do think big compounders ought to be under FDA oversight,” he said.
In the fall outbreak, the New England Compounding Center of Framingham, Mass., shipped more than 17,000 vials of steroid shots to doctors’ offices and clinics in 23 states. Some of the vials were contaminated; the outbreak killed 55 people and sickened 686. In the eight months since the NECC-linked meningitis infections, at least 48 compounding companies have been found to be producing and selling drugs that are contaminated or created in unsafe conditions, according to a report by the Senate committee.
Allison Preiss, a spokeswoman for Sen. Tom Harkin (D-Iowa), chair of the panel, said the bill is a work in progress and will continue to be refined as it moves through the legislative process.