POLICY BRIEFINGS


User Fee Reauthorization Sent To Full Energy and Commerce Committee


The House Energy and Commerce Health Subcommittee advanced the Food and Drug Administration Reauthorization Act (FDARA) last week. H.R. 2430 will reauthorize the FDA’s user fee programs through 2022. Four amendments were added to the bill during the committee markup. Reps. Joe Kennedy (D-Mass.) and Marsha Blackburn (R-Tenn.) offered an amendment to allow the purchase of over-the-counter (OTC) hearing aids. An amendment from Reps. Kurt Schrader (D-Ore.) and Gus Bilirakis (R-Fla.) would provide incentives for the development of generic drugs when there is no competition for the brand-name product. The third amendment, authored by Reps. Larry Bucshon (R-Ind.) and G.K. Butterfield (D-N.C.), would establish a risk-based medical device inspection process. Finally, the Committee approved an amendment from Chairman Michael Burgess (R-Texas) and Ranking Member Gene Green (D-Texas) that would protect the drug supply chain from diversion and counterfeiting by addressing statutory gaps in penalties. The Senate version of the bill has already been approved by the Health, Education, Labor, and Pensions (HELP) Committee. Current authorization for the user fee programs expires on September 30.


Administration Pushes for Increase in User Fees


U.S. Secretary of Health and Human Services (HHS) Tom Price has recommended that lawmakers increase the Food and Drug Administration’s (FDA) reliance on industry user fees. Congress is currently working to reauthorize the user fee programs, and has already come to an agreement with name-brand, generic, biosimilar, and device manufacturers. Under Secretary Price’s proposal, user fees would fund 100 percent of the FDA’s review of medical products, with no requirement of budget authority financing. Secretary Price’s request was not well received by the lawmakers who are attempting to advance reauthorization legislation as quickly as possible. Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Lamar Alexander (R-Tenn.) said that the request has come too late in the negotiation process, but could be considered in the future. Congress must send legislation to the President’s desk before the end of July in order to avoid triggering the FDA process to terminate the employment of 5,000 individuals.


Lawmakers Circulate OTC Legislation


Sens. Johnny Isakson (R-Ga.) and Bob Casey (D-Pa.) are circulating a draft bill that would reform the way that the Food and Drug Administration (FDA) regulates over-the-counter (OTC) products. The senators are proposing to streamline product approvals by eliminating the requirement that the agency do rulemaking for each therapeutic class. Instead, the Secretary would establish standards for each OTC drug type.


Legislation Introduced to Increase Access to Addiction Treatment


Bipartisan legislation has been introduced in the Senate that would expand access to addiction treatment by easing federal restrictions on Medicaid reimbursement for substance abuse treatment centers. The Medicaid Coverage for Addiction Recovery Expansion (Medicaid CARE) Act (S. 1169) was introduced by Sens. Dick Durbin (D-Ill.), Rob Portman (R-Ohio), Sherrod Brown (D-Ohio), Shelley Moore Capito (R-W.V.), Angus King (I-Maine), and Susan Collins (R-Maine) – all of whom represent states significantly impacted by the opioid abuse epidemic. Substance abuse treatment centers with up to 40 beds would be allowed reimbursement by Medicaid for up to 60 consecutive days. The Medicaid program is currently prohibited from paying for substance abuse treatment at centers with more than 16 beds, in order to
discourage institutionalization.


Lawmakers Request Better Oversight of Opioid Overprescribing


A group of Democratic lawmakers have written to the U.S. Drug Enforcement Agency (DEA), the Centers for Medicare and Medicaid Services (CMS), and commercial insurers requesting that they use data to improve oversight of opioid prescribing practices and to better hold prescribers accountable for overprescribing painkillers. “There are too many providers who are prescribing opioids at rates significantly higher than their peers, and there are too many regions of the country where opioid dispensing is far beyond sensible need,” the lawmakers write. They ask the agencies and insurers to examine the Part D Opioid Prescribing Mapping Tool for red flats, outliers, trends, or particular areas of concern about over-prescribing. The letters were signed by Sens. Dick Durbin (D-Ill.), Sherrod Brown (D-Ohio), Angus King (I-Maine), Amy Klobuchar (D-Minn.), and Tammy Duckworth (D-Ill.).



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