Senate Passes OTC Reform, VA Suicide Legislation

The Senate has passed legislation that would make changes to the way in which the Food and Drug Administration (FDA) regulates over-the-counter (OTC) drugs. The Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 (S. 2740) passed by a vote of 91-2. The bill would speed the process by which the agency reviews such products, and would create a user fee program to support the regulatory improvements. The bill will now be sent to the House, which already passed similar legislation earlier this year.

The Senate also passed the Support for Suicide Prevention Coordinators Act (H.R. 2333) by a vote of 95-0 last week. The bill would require the Government Accountability Office (GAO) to study and report on the Department of Veterans Affairs’ support for suicide prevention coordinators. Recent accounts have suggested that coordinators are overworked and unable to complete their responsibilities. The legislation passed the House of Representatives earlier this year, and will now be sent to the President’s desk for his signature.

Hahn Confirmed by Senate to Lead FDA

The Senate confirmed the President’s nominee for Commissioner of Food and Drugs, Dr. Stephen Hahn, by a vote of 72-18 last week. During the confirmation process, the Texas oncologist and MD Anderson executive faced scrutiny over how he plans to address the youth vaping epidemic. Senate HELP Committee Ranking Member Patty Murray (Wash.), Minority Leader Chuck Schumer (N.Y.), and Finance Committee Ranking Member Ron Wyden (Ore.) were among the Democrats who voted against the nomination.

House Passes Pelosiís Lower Drug Costs Now Act

The House of Representatives passed Speaker Nancy Pelosi’s Lower Drug Costs Now Act (H.R. 3) last week. The bill passed along a largely party-line vote of 230-192. Republicans Brian Fitzpatrick (Pa.) and Jaime Herrera Beutler (Wash.) voted in support of the bill, and no Democrats voted against it. The legislation aims to reduce the cost of prescription drugs by allowing the Secretary of the U.S. Department of Health and Human Services (HHS) to negotiate the price of certain treatments and capping annual out-of-pocket costs for Medicare beneficiaries at $2,000. The Secretary would be required to negotiate lower prices for a minimum of 50 drugs per year, up to a maximum of 250 drugs, capping a drug’s price at 120 percent of their cost in certain other wealthy nations. Progressive Democrats reached a deal with the Speaker’s office to increase the minimum number of drugs to be subject to negotiation from 35 to 50 shortly before passage of the bill. Lower prices would apply to both the Medicare program and private insurance. If a manufacturer refuses to negotiate, the company would be penalized with a tax up to 95 percent of their drug’s revenue. Republicans argue that such a steep penalty would effectively result in a government mandated price.

The Congressional Budget Office (CBO) estimates that the legislation would lower the prices of drugs subject to negotiation by 50 percent and save $456 billion over the next decade. Savings would be used to expand the Medicare benefit to include hearing, dental, and vision care. CBO expects the bill to raise wages for people with employer-sponsored health insurance by $116 billion over the same time period. CBO also predicts, however, that the bill would result in the development of eight fewer drugs over the next 10 years because manufacturers would cut back on research and development due to reductions in revenues as a result of the bill. CBO estimates that approximately 30 fewer drugs would be introduced over the subsequent decade.

The White House has issued a veto threat for H.R. 3, arguing that the bill would impose price controls on the industry and ultimately harm individuals in need of innovative new treatments. The administration is instead urging Congress to take up the bipartisan drug pricing legislation advanced out of the Senate Finance Committee. The Prescription Drug Pricing Reduction Act (S. 2543) would lower Medicare enrollee’s out-of-pocket expenses in the initial phase of a prescription drug plan from 25 percent to 20 percent and would allow beneficiaries the option to more evenly divide what they pay each month for their medications, capping out-of-pocket costs at $3,100 per year. It would also require drug companies to pay rebates to Medicare if they raise the price of their product more than inflation. Majority Leader Mitch McConnell (R-Ky.) has said that he will not bring H.R. 3 up for a vote, and it remains unclear if he will allow for consideration of the Finance package.

Lawmakers Reach Deal in Principle on FY2020 Funding

House Appropriations Chair Nita Lowey (D-N.Y.) and Senate Appropriations Chair Richard Shelby (R-Ala.) announced that they had reached a deal in principle to fund the federal government for the remainder of fiscal year (FY) 2020. While the details of the agreement remain unclear, Democrats have reportedly received assurances that the President will sign the appropriations bills. A vote on the legislation in the House is scheduled for Tuesday, and House Majority Leader Steny Hoyer (D-Md.) expects the bills to be grouped into at least two packages to be introduced today. The current stop gap spending measure expires on December 20.

House to Delay E-Cigarette Vote

The House of Representatives will wait until early next year to vote on legislation to ban flavored e-cigarette products, according to cosponsor of the bill Donna Shalala (D-Fla.). Shalala blamed the limited number of working days remaining in 2019, and the focus on funding the federal government, for the delay. She had previously stated that the bill would get a vote by the end of the year. The legislation would also increase the tobacco purchasing age to 21 and restrict the online sale of e-cigarettes.

USMCA Removes Biologic Exclusivity Provision

The White House has reached an agreement with House Democrats on the U.S.-Mexico-Canada trade agreement (USMCA). The House plans to vote on the deal this week. While the administration has stated that it will push to implement the bill before the end of the year, Senate Majority Leader Mitch McConnell (R-Ky.) said that the Senate will not take up the USMCA until after the President’s impeachment trial next year. Representatives from Canada, Mexico, and the U.S. met on Tuesday to sign the amendments to the trade agreement. The revised deal removes a provision that would have guaranteed 10 years of data protection for biologic drugs, a change strongly supported by Democrats. Despite this and other several other concessions to Democrats, Republicans in both chambers have expressed confidence that the trade agreement will pass.

Bipartisan Lawmakers Raise Concerns with Medicare Plan Finder

Bipartisan committee leaders in the House have written to the Centers for Medicare and Medicaid Services (CMS) to express concerns about the accuracy of the Medicare Plan Finder. The letter was sent following reports from consumer advocates, volunteers, and other Medicare counselors that the tool was confusing, provided incorrect results, and led beneficiaries to choose plans with lower premiums but higher overall costs. The letter was signed by E&C Chairman Frank Pallone (D-N.J.), Ranking Member Greg Walden (R-Ore.), Ways and Means Chairman Richard Neal (D-Mass.), and Ranking Member Kevin Brady (R-Texas). The lawmakers urge CMS Administrator Seema Verma to evaluate and correct errors with the Plan Finder as necessary. Because Medicare open enrollment has closed, the letter also requests that beneficiaries who used Plan Finder be included in a special enrollment period to allow them to make changes to their plan selection. The leaders request a response from CMS by December 30.

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