HELP committee advances public health bills

Among a series of bills voted on by the Senate Health, Education, Labor and Pensions (HELP) committee on April 26, 2017 were bills focused on access to medications in emergency situations (Protecting Patient Access to Emergency Medications Act of 2017 (S. 916)) and hearing loss screening for children (Early Hearing Detection and Intervention Act (S. 652)). Also sent to the Senate floor were two other public health bills which would create a national commission on clinical care (S. 920) and better prepare the public health community for Zika and other mosquito-borne diseases (S. 849).

S. 916

The Protecting Patient Access to Emergency Medications Act seeks to amend the Controlled Substances Act to make it easier for first responders and those providing emergency medical services to have access to “time-sensitive and life-saving treatments.” The bill is sponsored by Sen. Bill Cassidy (R-La) and co-sponsored by Sens. Michael F. Bennet (D-Colo), Roy Blunt (R-Mo), and Al Franken (D-Minn).

S. 652

The Early Hearing Detection and Intervention Act is sponsored by Sen. Rob Portman (R-Ohio) and co-sponsored by Sens. Tim Kaine (D-Va), Sheldon Whitehouse (D-RI), John Cornyn (R-Texas, Sherrod Brown (D-Ohio), and Richard Blumenthal (D-Conn). The bill aims to improve state-based efforts to screen newborns, infants, and young children with hearing loss screening and link them to follow-up care if needed by amending sec. 399M of the Public Health Service Act. The Health Resources and Services Administration (HRSA), the Centers for Disease Control and Preventions, and the National Institutes of Health would need to coordinate and collaborate these efforts with those administering such programs as the Medicaid Early and Periodic Screening, Diagnosis and Treatment (EPSDT) program, for example.

FDA’s line of ‘thinking’ via draft guidances draws lawmakers’ attention

Members of the Senate Health, Education, Labor, and Pensions (HELP) Committee, including Senator Lamar Alexander (R-Tenn), asked the FDA to explain why draft guidances were not being revised, finalized, or withdrawn in a timely manner. In a letter expressing concern on the matter, the lawmakers asked the FDA to update information and provide answers to questions regarding (1) the length of time it took for each FDA center to finalize a draft guidance, previously reported as between 425 and 797 days; (2) the number of still-pending draft guidances published prior to December 31, 2013, previously reported as standing at 172; (3) current work plans to address draft guidance review; and (4) FDA staff training on the use of draft guidances in the absence of a final guidance document.

Although the senators applauded the implementation of easy-to-use navigation of guidance documents on the FDA website, the lawmakers stressed that it should be kept as up to date as possible. In the previous 12 months, the FDA took action to withdraw 47 guidance documents that it considered “outdated and unfinished.”

However, the lawmakers noted that industry members, including physicians and corporations, were concerned about the agency’s reliance on draft guidances to carry out regulatory responsibilities. As such, industry felt compelled to follow the draft guidances as if final, even if the most up-to-date information suggested an alternative path. The lawmakers noted that the FDA was periodically sending, as well as publicizing, “It has come to our attention” letters that relied upon new “thinking” only previously discussed in a draft guidance to raise concerns about a current regulated product.