Upton Working on New Version of Cures

In an effort to pass his signature medical innovation legislation, House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) is working on a new version of the 21st Century Cures Act (H.R. 6), which could be introduced as early as this week. Upton hopes to pass the new bill through the House before the elections, and have it taken up by the Senate during lame duck. The House passed H.R. 6 in a bipartisan vote in July of last year, but legislation has struggled to move in the Senate due to disagreements about offsets for new spending at the National Institutes of Health (NIH).

Justice Department Announces Plan to Address Opioid Abuse

In an interview with USA Today, Attorney General Loretta Lynch announced a new strategy to address the nation’s heroin and opioid abuse epidemic. The plan aims to identify links between over-prescribing doctors and distribution networks across the country. Lynch said that she will urge prosecutors to share information about overprescribing doctors, and the resulting illegal trafficking. She will also call on prosecutors to coordinate with public health authorities on prevention and treatment efforts. A memo is expected to be circulated this week to all 94 U.S. attorney offices. In related news, the President declared September 18-24 “Prescription Opioid and Heroin Epidemic Awareness Week.” More than 160 events
will be held by the Administration across the country to raise awareness of the crisis and pressure Congress to authorize funding to increase access to addiction treatment.

Biosimilar User Fee Agreement Reached

The Food and Drug Administration (FDA) and the pharmaceutical industry have agreed to terms for the next Biosimilar User Fee Agreement. Under the new agreement, which goes into affect in fiscal year (FY) 2018, the FDA will have an additional 60 days to review biosimilars. This extended time period will allow for increased interaction between FDA and industry during the process, in the hopes that products can be approved in the span of a single review. The agency has agreed to decrease the review time of manufacturing changes from six to four months. The deal also includes changes to biosimilar fee structures. The FDA expects to generate $45 million in user fee revenue during the first year of the agreement. A public meeting will be held on October 20 to gather public comments before the proposal is sent to Congress for reauthorization by the fall of 2017.

Upcoming Congressional Hearings and Markups

House Veterans’ Affairs Committee field hearing titled “An Assessment of Deficiencies at the Northport VA Medical Center;” 9:00 a.m. (local time), Northport VA Medical Center, Auditorium, 79 Middleville Road, Northport, NY 11768; September 20

Senate Health, Education, Labor and Pensions Committee hearing titled “Laboratory Testing in the Era of Precision Medicine;” 10:00 a.m., 430 Dirksen Bldg.; September 20

House Energy and Commerce Committee markup of H.R. 2566, Improving Rural Call Quality and Reliability Act of 2016; H.R. 4365, Protecting Patient Access to Emergency Medications Act of 2016; H.R. 1192, National Clinical Care Commission Act; H.R. 1209, Improving Access to Maternity Care Act; H.R. 1877, Mental Health First Aid; H.R. 2713, Title VIII Nursing Workforce Reauthorization Act of 2015; H.R. 3537, Synthetic Drug Control Act of 2015; 5:00 p.m., 2322 Rayburn Bldg.; September 20

Senate Health, Education, Labor and Pensions Committee markup of S.2873, the “Expanding Capacity for Health Outcomes (ECHO) Act”; S.2932, the “Protecting Patient Access to Emergency Medications Act of 2016”; and the “Career and Technical Education Act of 2016”; 9:30 a.m., 430 Dirksen Bldg.; September 21

House Oversight and Government Reform Committee hearing on Epi-Pen product price increases; 10:00 a.m., 2154 Rayburn Bldg.; September 21

Senate Homeland Security and Governmental Affairs Committee hearing titled “Combatting the Opioid Epidemic: A Review of Anti-Abuse Efforts by Federal Authorities and Private Insurers Permanent Subcommittee on Investigations;” 10:00 a.m., 342 Dirksen Bldg.; September 21

Senate Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee hearing on the Food and Drug Administration’s role in the generic drug marketplace; 2:30 p.m., 192 Dirksen Bldg.; September 21

Senate Health, Education, Labor and Pensions Committee hearing titled “Exploring Current Practices in Cosmetic Development and Safety;” 10:00 a.m., 430 Dirksen Bldg.; September 22

House Energy and Commerce Oversight and Investigations Subcommittee hearing titled “Bioresearch Labs and Inactivation of Dangerous Pathogens;” 9:00 a.m., 2322 Rayburn Bldg.; September 23

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