POLICY BRIEFINGS


Right-to-Try Bill Passes House


The House of Representatives passed H.R. 5247, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act, by a vote of 267-149 last week. Thirty-five Democrats voted for the bill, and two Republicans opposed it. The legislation would allow terminally ill patients who are ineligible for clinical trials and who have exhausted other available treatments to request access to experimental medicines that have not yet been approved by the Food and Drug Administration (FDA). Patients could request access to medicines without the permission of or oversight from the agency as long as the product has gone through a small-scale clinical trial and is currently under FDA consideration. The House attempted to pass the bill though expedited process last week but could not garner the two-thirds majority necessary for success.

Many Democrats oppose the bill because of concerns about patient safety. House Energy and Commerce Committee Ranking Member Frank Pallone (D-N.J.) pushed for adoption of an alternative proposal that would encourage pharmaceutical manufacturers to use the FDA’s existing compassionate use program, but the plan did not gain any traction. Four former FDA commissioners also spoke out against right-to-try last week, arguing that the policy would erode protections for vulnerable patients. Commissioners Robert Califf and Margaret Hamburg, who served during the Obama Administration, and Mark McClellan and Andrew von Eschenbach, who served during the George W. Bush Administration, contend that there is no evidence that right-to-try would meaningfully improve access to treatments for patients.

Following Senate passage of the omnibus, Sen. Ron Johnson (R-Wis.) pushed for a vote on H.R. 5247, but Senate Minority Leader Chuck Schumer (D-N.Y.) objected. Johnson then called on the House to pass S. 204, his own version of the bill, which unanimously passed the Senate last year. Right-to-try is strongly supported by Vice President Pence and was cited as a priority for President Trump in his State of the Union address.


President Appoints New CDC Director


The White House announced the appointment of Robert Redfield, MD to be Director of the Centers for Disease Control and Prevention (CDC) and Administrator of the Agency for Toxic Substances and Disease Registry (ATSDR). Redfield worked as an HIV/AIDS researcher for two decades at Walter Reed Army Institute of Research and co-founded the Institute of Human Virology. He previously served on President George W. Bush’s advisory council on HIV/AIDS and was also an advisor to the NIH during the Bush Administration. The White House touted Redfield’s recent experience running a treatment network for HIV and Hepatitis C patients in Baltimore as good preparation for leading the CDC’s efforts to combat the opioid crisis. Former CDC Director Brenda Fitzgerald resigned in January follow reports that she had traded tobacco, drug, and food stocks while heading the agency. The position does not require Senate confirmation.

Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Patty Murray (D-Wash.) has expressed concerns about Redfield’s past support for a number of controversial policies, such as mandatory patient HIV testing in the 1980s, and urged the Administration to reconsider its choice of candidates.


Latest Staff Changes at HHS


John Bardis, Assistant Secretary of Administration at the U.S. Department of Health and Human Services (HHS), has announced plans to resign effective April 6. Bardis’ office has been the subject of an internal probe by the Office of the Inspector General (OIG) for signing off on the use of charter-jet flights for routine domestic travel, leading to the resignation of former HHS Secretary Tom Price. Bardis indicated that he plans to return to the private sector. It remains unclear who will be responsible for Bardis’ portfolio at HHS following his departure.

It was also announced that John Brooks, counselor to the Secretary, is moving to a position on the White House Domestic Policy Council. At HHS, Brooks was responsible for advising the Secretary on drug pricing, the Centers for Medicare and Medicaid Services (CMS), the Health Resources and Services Administration (HRSA), the Agency for Healthcare Research and Quality (AHRQ), and the Office of the Assistant Secretary for Planning and Evaluation (ASPE). John O’Brien, Deputy Assistant Secretary at ASPE, will assume Brooks’ former position.


MS Governor Announces Cochranís Replacement


Mississippi Commissioner of Agriculture and Commerce Cindy Hyde-Smith has been picked by Governor Phil Bryant (R) to fill the seat vacated by Sen. Thad Cochran (R-Miss.), who announced his resignation from the Senate last week amid health challenges. Hyde-Smith will serve in his place until a replacement is picked in the November 6 election. The winner of the special election will serve the remainder of Cochran’s term, which ends in January 2021.


Lawmakers Request Info on Medicaid Rebate Program


A group of bipartisan members of the House Energy and Commerce Committee and Senate Finance Committee have written to the Centers for Medicare and Medicaid Services (CMS) regarding agency oversight of the Medicaid drug rebate program. The lawmakers express concerns about the misclassifications of certain prescription drugs that have resulted in inappropriately high Medicaid expenditures. The Office of the Inspector General (OIG) found that misclassifications of 10 drugs cost the Medicaid program $1.3 billion in improper rebates. The lawmakers request more information on what steps CMS has taken to address these errors, and whether the agency needs broader authority to ensure better compliance with current law.



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