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Volume 39, Issue 3
Wide-ranging probes to target marketing, pricing, and access.
Both Republican and Democratic committee chairs will be busy in the coming months with a broad range of investigations and hearings on topics that involve pharmaceutical marketing, pricing, access, and shortages.
Drug benefits will figure in the continuing debate about health reform and insurance coverage and cost, including the “Medicare for all” campaign. International trade policy deliberations will raise questions about extended patents for biologics. Medical device makers have renewed their campaign to permanently repeal the
2.3% device excise tax created by the Affordable Care Act (ACA). And FDA is pressing for legislation to reform how it regulates over-the-counter drugs, including new user fees to expand agency resources in this area. While many Democratic proposals approved by the House will fall by the wayside in the Republican-controlled Senate, both parties are eager to address public concerns about access to affordable health care and prescription medicines.
The opioid epidemic will be a continuing focus for the legislators. House Democrats are expected to continue Republican investigations on opioid production and distribution, including the rise in fatal overdoses from fentanyl and other synthetic opioids. At the same time, the concerns of patients in need of pain therapies will be aired, as seen at a recent hearing before the Senate Health, Education, Labor and Pensions (HELP) committee, which invited patients suffering from chronic pain to testify on how initiatives to curb opioid supply may harm many individuals.
The recent measles outbreak also has drawn attention. The House Energy and Commerce subcommittee on Oversight and Investigations held a hearing on how the anti-vaccination trend was leading to the reemergence of this and other preventative diseases. Similarly, the Senate HELP panel heard testimony recently on how vaccines save lives.
FDA policies and programs will be examined, as seen in a query from leaders of the House E&C panel on the agency’s ability to adequately inspect and detect safety issues at foreign drug manufacturers. The concern arises from the discovery of a contaminated ingredient in common blood pressure medicines, which has led to extensive recalls.
The really hot topic for legislators on both sides of the aisle, though, is cost and access to prescription drugs. House and Senate committees wasted no time scheduling hearings on drug pricing, including Trump administration proposals to change how Medicare pays for drugs, establish some kind of reference pricing system, and alter industry-payer negotiation of rebates and discounts. The House Ways & Means Committee, the Senate Finance Committee, and the House Oversight and Reform Committee have all held sessions to hear from experts and patients on proposals to revise drug rebates, permit drug importation from Canada (and elsewhere), modify curbs on Medicare Part D price negotiations, reduce barriers to competition from generic drugs, and set international reference pricing standards. A continuing focus will be stiff hikes in the cost of insulin and other diabetes treatments.
Senate Finance Committee chair Chuck Grassley (R-Iowa) and ranking Democrat Ron Wyden (D-Ore) are setting an aggressive pace. In February, the panel invited leading pharma CEOs to testify on drug marketing and pricing issues, particularly on rationales for highly publicized January price hikes by Pfizer, Merck & Co., Bristol-Myers Squibb, Sanofi, and Astra-Zeneca. Grassley has long challenged “pay-for-delay” deals between innovators and generics, and plans a major push to further curb such arrangements. And Wyden has introduced a handful of bills that require pharma companies to justify publicly list price increases beyond established benchmarks, to provide greater transparency in rebates and discounts negotiated with pharmacy benefit managers (PBMs), and to reduce the costs that hit Medicare beneficiaries under catastrophic coverage.
But everyone is looking for real solutions and not more finger-pointing. At a Ways & Means Committee hearing in February, chairman Richard Neal (D-Mass) complained that “drug companies point to the PBMs, who point to the insurance companies, who point to the hospitals,” noting that patients are the victims as a result.
Jill Wechsler is Pharmaceutical Executive’s Washington Correspondent. She can be reached at firstname.lastname@example.org