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Capitol Connections Article S. 959 Update CQ Quarterly 07.26.13
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Compounding Pharmacy Bill Could Be Blocked From Speedy Senate Passage

By Emily Ethridge, CQ Roll Call

Senate Health, Education, Labor and Pensions Committee leaders may not achieve their goal of gaining unanimous Senate consent for a modified version of their bill to clarify the oversight of compounding pharmacies.

Committee Chairman Tom Harkin, D-Iowa, and ranking Republican Lamar Alexander of Tennessee plan to request that the bill, with a substitute amendment, be hotlined in the coming days, according to an aide.

But Oklahoma Republican Tom Coburn said Thursday that more time and review was necessary before the bill could be passed under unanimous consent.


“It needs to get out there and be seen by people so we can hear what the industry thinks and everybody that’s a stakeholder thinks,” Coburn said. “Then I don’t have any problem, but [Harkin] shouldn’t do it too soon.”

Asked if before the August recess was too soon, Coburn replied, “I think so.”

The measure (S 959) would increase the Food and Drug Administration’s oversight of compounding pharmacies that manufacture sterile products without patient prescriptions and sell them across state lines. The HELP Committee approved the bill by voice vote in May.

Harkin and Alexander have urged Senate leaders to bring the bill to the floor since then, saying that public health is at risk. The committee approved the bill following an outbreak of fungal meningitis linked to a contaminated steroid injectable drug that killed 61 people, according to the Centers for Disease Control and Prevention.

Many House Republicans have said they oppose the Senate bill but would be open to a different approach. Earlier this month, a House Energy and Commerce subcommittee reviewed a draft proposal from Virginia Republican Morgan Griffith, the Senate bill and a proposal (HR 2186) from former Rep. Edward J. Markey (D-Mass.), who is now a senator.


The Senate committee leaders’ substitute amendment appears to make mostly technical changes, with a few additions. The bill would leave oversight of traditional compounding pharmacies up to states, while the FDA would regulate pharmacies that compound sterile products without a prescription and sell them across state lines.

The bill would ban compounding of some types of drugs, including marketed drugs and drugs that have been removed from the market for safety and efficacy concerns. And the Health and Human Services secretary could promulgate a list of drugs that are demonstrably difficult to compound and cannot be compounded.

Compounding manufacturers would be required to register with the FDA and report any adverse events, and pay establishment and reinspection fees. The bill would allow the FDA to conduct investigations of compounding manufacturers on a risk-based schedule. The substitute amendment clarifies that the FDA will list the names of each compounding pharmacy along with the state where it is registered, whether it compounds from bulk drug substances, and whether the bulk compounding is sterile or non-sterile.

The substitute amendment adds a provision for when a traditional compounding pharmacy can dispense a compounded drug to a health care entity for office use. It would allow states to issue regulations on compounded drugs for office use that are more stringent than the bill’s requirements, and allow the requirements to be waived for emergency medical reasons.

The substitute amendment also clarifies that only a single notice to the FDA is required when compounder wants to copy an FDA-approved drug that is in shortage. It also says that compounding manufacturers can only compound non-sterile drugs that are included on a list developed by the FDA.

It also adds a provision allowing the HHS secretary to establish a list of non-sterile drugs that can be compounded by a compounding manufacturer.

The bill also contains language to create a national unit-level system to track prescription drugs, also known as “track and trace,” over 10 years. Under the legislation, the FDA would be authorized to conduct pilot projects and hold public meetings for comment on moving toward the interoperable, electronic, unit-level system.

The substitute amendment clarifies that four years after the law’s enactment, manufacturers must electronically provide transaction information, transaction history and transaction statements of their serialized products to their authorized trading partners

The substitute amendment clarifies that dispensers and wholesale distributors must trade only with authorized trading partners.

The Congressional Budget Office found that the bill as amended would have no net increase or decrase in the deficit over fiscal 2013 to fiscal 2013. An earlier budget score on the bill as approved by the HELP committee found that implementation would cost $31 million between fiscal 2014 and fiscal 2018, assuming that Congress appropriates the requested funding. In that report, the CBO said that implementing the bill’s compounding pharmacy provisions would cost about $74 million over that time period, but that cost would be more than fully offset by the fees the bill authorizes the FDA to collect.


Niels Lesniewski contributed to this report.



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