US Senate Committee To Hold Hearing on Drug Pricing

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-09-2017 10:04


The US Senate Committee on Health, Education, Labor and Pensions (HELP) will hold a hearing next week, on Tuesday June 13, to discuss prescription drug pricing. The hearing's focus is The Cost of Prescription Drugs: How the Drug Delivery System Affects What Patients Pay.  The issue of drug pricing has become a subject of recent discussion in Congress and under the Trump administration.

The HELP Committee's jurisdiction encompasses most of the agencies, institutes, and programs of the Department of Health and Human Services, including the Food and Drug Administration, the Centers for Disease Control and Prevention, the National Institutes of Health, the Administration on Aging, the Substance Abuse and Mental Health Services Administration, and the Agency for Healthcare Research and Quality.

In May 2017, the HELP Committee introduced a bill to address drug pricing, S.1131, the Fair Accountability and Innovative Research Drug Pricing Act of 2017, sponsored by Sens. Tammy Baldwin (D-WI) and John McCain (R-AZ). Companion legislation in the US House of Representatives is sponsored by Representative Jan Schakowsky (D-IL).

The Fair Accountability and Innovative Research (FAIR) Drug Pricing Act would require drug manufacturers to disclose and provide more information about planned drug price increases, including research and development costs. Specifically, the FAIR Drug Pricing Act would require drug manufacturers to notify the US Department of Health and Human Services and submit a transparency and justification report 30 days before they increase the price of certain drugs that cost at least $100 by more than 10% in one year or 25% over three years. The report will require manufacturers to provide a justification for each price increase as well as manufacturing and research and development costs for the qualifying drug, net profits attributable to the qualifying drug, marketing and advertising spending on the qualifying drug, and other information as deemed appropriate. The bill will not prohibit manufacturers from increasing prices, but it would provide notice of price increases and is intended to bring basic transparency to the market for prescription drugs.

Earlier this month, the new Commissioner of the US Food and Drug Administration (FDA), Dr. Scott Gottlieb, testified before the Subcommittee of the Agriculture, Rural Development, Food and Drug Administration (FDA), and Related Agencies of the Appropriations Committee of the US House of Representatives, where he identified that one of his key priorities for the agency was to increase competition to help mitigate high drug costs. Although the FDA is not directly involved in drug pricing, Dr. Gottlieb, said that there are several measures that the FDA can take to increase competition of lower-cost alternatives by improving the generic-drug review process. He added the FDA plans to issue a drug competition action plan in the near term to address this issue. He also highlighted several areas to improve the review process for generic drugs, including improved communication between the FDA and generic drug companies individually and collectively through more helpful guidance documents. .

Source: US Senate Committee on Health, Education, Labor and Pensions and Joint Statement by Sens.Tammy Baldwin, John McCain and Representative Jan Schakowskye


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