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Breaking News: CQ Legislative Update 11.6.13
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HR 3204 Legislative Update

Congressional Quarterly News (Nov. 5, 2013 – 2:17 p.m.)

No Mandate for FDA Oversight of Large Compounding Pharmacies in Bill

By Emily Ethridge, CQ Roll Call

Criticism of a provision in a compromise bill that would allow compounding pharmacies to choose to be regulated by the Food and Drug Administration — rather than requiring them to be subject to federal government oversight — will likely not stop the measure from clearing the Senate.

The bipartisan bill (HR 3204) would create a new category of “outsourcing facilities” for companies that compound large volumes of drugs without receiving patient prescriptions. While outsourcing facilities would be required to meet a number of Food and Drug Administration standards, choosing to become an outsourcing facility would be voluntary.

The legislation represents an attempt by lawmakers to respond to a highly publicized fatal outbreak of fungal meningitis linked to the New England Compounding Center, a now-closed business that manufactured a contaminated sterile drug. The Centers for Disease Control and Prevention says the outbreak is the largest of health-care-associated infections ever reported in the United States, and counted 751 cases of fungal meningitis and 64 deaths linked to the drugs, as of Oct. 23.

FDA Commissioner Margaret Hamburg said Tuesday that she believes the Senate will vote on the legislation “probably next week.” Of the compromise bill, she said, “It’s a step. I don’t think that it’s going to be as comprehensive as maybe we initially had hoped.” Her remarks came at a health care summit sponsored by Bloomberg Government.

Under the bill agreed to by House and Senate negotiators, traditional compounding pharmacies, which make individual drugs for a specific prescription, would continue to be overseen by state boards of pharmacy. But the bill’s language allows companies to choose whether to opt in to the new category and be regulated by the FDA.

Critics of the provision, including Rep. Rosa DeLauro, D-Conn., say giving companies a choice weakens the bill. Those objections were not enough to stop the House from passing the bill in September, however, and it does not appear they will present a major roadblock on the Senate floor.

Allison Preiss, press secretary for Senate Health, Education, Labor and Pensions Committee Chairman Tom Harkin, D-Iowa, said in a statement the bill would give providers “the option to use compounded drugs from facilities that comply with FDA quality standards, undergo regular inspections, provide information to FDA about what they are compounding, and disclose to FDA any adverse event reports.”

Bill supporters say the provision would give a sort of business “seal of approval” for outsourcing facilities. They expect purchasers would want to buy products from facilities that have chosen to register with the FDA and meet other federal requirements.

“The effect of this in some ways is going to have to be seen if and when the bill is passed, because there’s a question of market factors here,” said Gabrielle Cosel, project manager of the Drug Safety Project at Pew Charitable Trusts, which supports the measure. “Hospitals are the main purchasers from these outsourcing facilities and will now have an option to buy drugs that have a higher level of quality assurance.”

Cosel added that the bill would clear a regulatory gray zone for many companies, essentially giving them permission to compound products on a greater scale.

Critics, however, say the voluntary approach will continue to allow companies to act as they have been — without strong penalties. Critics note that the bill could allow a facility like the NECC to continue to compound large amounts of sterile products without being subject to FDA oversight. “Given the willful malfeasance of many compounding manufacturers it is highly unlikely that a voluntary registration process will change their behavior,” said Dave Sterrett, health care counsel at Public Citizen, in an email.

DeLauro opposed the compromise bill for that reason, saying it would rely on large compounders to voluntarily register with the FDA without imposing any meaningful penalties on those that do not.

“This voluntary approach will continue to expose patients to potentially unsafe, mass-produced compounded drugs that are not approved or evaluated by the FDA for safety, efficacy and adequate directions for use,” said DeLauro on the House floor in September. “It is an approach that can do real harm.”

She advocated for her bill (HR 3019) that would require compounding facilities to register with the FDA and require all compounded drugs be labeled as such, among other provisions.

Supporters of the bill say that even with the voluntary process, the measure would clarify who is responsible for regulating each compounding operation. Compounders that do not register as an outsourcing facility would be regulated by their state boards of pharmacy — so no matter, one entity would be primarily in charge of regulating that compounding operation, they say.

“We’re very optimistic that this new category will enable these facilities ... to have the right regulatory home,” said Cosel.

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