Regulatory Roundup

Compounding, tracking legislation moves forward
Jul 02, 2013
Volume 37, Issue 7

Compounding, tracking legislation moves forward
Bills setting new rules for drug compounding and distribution through the supply chain are moving forward in the House and Senate, but clear divergence on specific provisions makes the final outcome uncertain. A bipartisan Senate measure would give FDA greater authority to regulate a new category of commercial compounders—large-scale operators that sell risky injectibles across state lines without prior individual prescriptions, while leaving "traditional" pharmacy compounders under state law. The Senate Health, Education, Labor & Pensions (HELP) Committee linked this compounding bill to a measure establishing an electronic tracking system for prescription drugs, starting with lot-level tracking and shifting to a unit-level traceability system over 10 years.

The House recently approved legislation that establishes an "enhanced" drug-tracking system, but without any clear path to unit-level reporting. House Republicans, however, propose only minor changes to FDA control over compounders, claiming that the agency has sufficient authority to regulate illegal operators and should do that more effectively. Both House and Senate track-and-trace bills pre-empt state laws, which has drawn opposition from California members of Congress who oppose any federal drug-tracking system that is less stringent than the one set for implementation in California. Congressional leaders have talked about enacting legislation by August, but it may take longer.

Medicare drug pricing
The 10-year anniversary of the Medicare prescription drug program (Part D) has brought praise for how it has extended access to medicines for nearly 50 million beneficiaries, along with questions about its costs and limitations. An analysis by consultants Avalere Health for drugmaker UCB finds that Part D plans cover fewer anticonvulsant drugs than commercial insurance plans and impose higher cost sharing that limits access (1). Meanwhile, the Senate Special Committee on Aging has asked the Government Accountability Office (GAO) to examine Part D spending, oversight of coverage and pricing information, and the program's potential for fraud and abuse. Sen. Ben Nelson of Florida, chairman of the Committee on Aging, seeks support for legislation requiring drug manufacturers to pay Medicaid rebates on medicines provided to low income "dual eligible" beneficiaries. That policy is calculated to raise $140 billion over 10 years and faces strong opposition from pharmaceutical companies.

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