House Energy and Commerce Committee

This week the House Energy and Commerce Committee held a 2-day hearing that included 19 witnesses and covered 25 public health bills that address the opioid misuse and overdose epidemic.  The Committee plans to hold a third hearing on Medicare, Medicaid and other payer issues related to the epidemic next month.  As we have previously reported, Chairman Walden (R-OR) wants the Committee to complete its work on a bill or bills by Memorial Day.

Senate HELP Committee

Senate Health, Education, Labor and Pensions (HELP) Committee Chair Alexander (R-TN) had previously said he hoped his Committee would begin considering legislation to address the epidemic before the spring recess, but consideration has now officially slipped until April.  The Committee may hold a legislative hearing on April 11 and may release a draft discussion bill around the same time.

RIGHT TO TRY LEGISLATION

After failing to secure the votes for passage under an expedited process last week, this week the House of Representatives again voted on and then passed what is commonly called the “Right To Try Act”.

The legislation (HR 5247) allows terminally ill patients who have unsuccessfully exhausted all available treatments for their conditions to enter into treatment plans with drugs not yet approved by the FDA.  Eligible patients would waive various patient safety requirements in order to try the drug, provided it has completed Phase I trials.

Supporters argue that the patients will die within months, so providing them the “right to try” experimental drugs could be the only opportunity to save their lives. Critics of the bill claim the FDA already has a “right to try” program called the Expanded Access program.  Further, they believe that nothing under the legislation would provide anything which is not already available under Expanded Access.

Last night, an effort lead by Sen. Johnson (R-WI) to move his right-to-try bill failed in the Senate; Johnson said he would continue working to get a bill through the chamber.  The Senate previously passed Johnson’s right-to-try bill last summer, but the bill then faced criticisms from patient advocate groups and Food and Drug Administration (FDA) Commissioner Gottlieb.

TRUMP ADMINISTRATION

New CDC Director

The Trump administration on Wednesday announced that HIV/AIDS researcher Robert Redfield will be the new director of the Centers for Disease Control and Prevention. The appointment does not require Senate confirmation. Redfield takes over for Anne Schuchat, who has been CDC acting director since the end of January when Brenda Fitzgerald, the Administration’s first choice, resigned.