FDA Commissioner Confirmed

The Senate confirmed Scott Gottlieb, MD as Commissioner of Food and Drugs by a vote of 57 to 42 last week. The following Democrats joined Republicans in supporting the nomination: Sens. Michael Bennet (D-Colo.), Tom Carper (Del.), Chris Coons (Del.), Heidi Heitkamp (N.D.), Angus King (I-Maine), and Bill Nelson (Fla.). Lawmakers commented on the timeliness of the confirmation, and expressed confidence that Dr. Gottlieb would begin work to address the opioid crisis, reauthorization of the user fee programs, and implementation of the 21st Century Cures Act.

HELP Advances FDA User Fee Reauthorization Bill

The Senate Health, Education, Labor, and Pensions (HELP) Committee advanced legislation to reauthorize the Food and Drug Administration’s (FDA) user fee programs last week by a vote of 21-2. Sen. Bernie Sanders (I-Vt.) and Sen. Rand Paul (R-Ky.) voted against the measure. S. 934 would reauthorize the programs for fiscal years (FY) 2018 through 2022. The manager’s amendment to the FDA Reauthorization Act (FDARA) adds a number of provisions beyond user fee program reauthorization related to pediatric drugs and devices, bioequivalence, device inspections and regulations, indications of contrast agents, and the availability of over-the-counter (OTC) hearing aids. Two additional amendments were added to the bill, one from Sens. Orrin Hatch (R-Utah), Michael Bennet (D-Colo.), Richard Burr (R-N.C.), and Bob Casey (D-Pa.) on expanded access to drugs and one from Sens. Susan Collins (R-Maine) and Al Franken (D-Minn.) on generic drugs and competition. Current authorization for the user fees expires on September 30. The bill now moves to the full Senate for consideration. The House Energy and Commerce Committee is expected to schedule consideration of FDA user fees legislation later this month.

HELP to Schedule Hearing on Drug Pricing

During the markup of legislation to reauthorize the Food and Drug Administration’s (FDA) user fee programs, Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Lamar Alexander (R-Tenn.) announced plans to hold a hearing on U.S. prescription drug prices. The hearing comes at the bipartisan request of several committee members including Al Franken (D-Minn.), Bill Cassidy (R-La.), Tammy Baldwin (D-Wisc.), Susan Collins (R-Maine), Sheldon Whitehouse (D-R.I.), Lisa Murkowski (R-Alaska), Bernie Sanders (I-VT), Shelley Moore Capito (R-WV), Elizabeth Warren (D-Mass.) and Mike Enzi (R-Wyo.). The Chairman responded to the senators saying that the hearing will be scheduled in the near future.

Senators Back ONDCP Funding

A bipartisan group of senators have written to the Trump Administration requesting that they fully fund the Office of National Drug Control Policy (ONDCP) in the White House fiscal year (FY) 2018 budget. The letter to the Office of Management and Budget (OMB) Director Mick Mulvaney cites the success of the ONDCP in fighting drug abuse and addiction. The White House has proposed cutting nearly the entire budget of the ONDCP – reducing its funding by 95 percent. “Eliminating critical prevention and enforcement programs would endanger our efforts to confront the drug overdose epidemic that has gripped our nation,” the lawmakers write. The letter was led by Sen. Dianne Feinstein (D-Calif.) and Sen. Chuck Grassley (R-Iowa) and was signed by 11 other bipartisan senators.

Lawmakers Request Clarification on HHS Whistleblower Memo

Senate Judiciary Committee Chairman Chuck Grassley (R-Iowa) and House Oversight Committee Chairman Jason Chaffetz (R-Utah) have written to U.S. Department of Health and Human Services (HHS) Secretary Tom Price regarding HHS staff’s ability to speak to lawmakers. Agency employees received a memo telling them to contact the Office of the Assistant Secretary for Legislation prior to speaking with members of Congress. “Protecting whistleblowers who courageously speak out is not a partisan issue — it is critical to the functioning of our government,” the letter states. The lawmakers request that Secretary Price issue a clarification telling federal workers that they have a right to contact members of Congress.

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