Washington, D.C.-House and Senate leaders finally agreed on compromise legislation to renew prescription user fees late last month, just a few days before the funding program was set to expire. The Food and Drug Administration legislation increases drug user fees by $225 million over five years, in addition to adopting user fee agreements negotiated with pharmaceutical, biotech and medical device companies that already raised fees considerably. There's also a new fee program to support FDA pre-review of DTC television ads.
WASHINGTON, D.C.-House and Senate leaders finally agreed on compromise legislation to renew prescription user fees late last month, just a few days before the funding program was set to expire. The Food and Drug Administration legislation increases drug user fees by $225 million over five years, in addition to adopting user fee agreements negotiated with pharmaceutical, biotech and medical device companies that already raised fees considerably. There's also a new fee program to support FDA pre-review of DTC television ads.
One important late compromise was to retain six-month exclusivity for sponsors that conduct studies providing pediatric labeling information, defeating a move to limit exclusivity to three months for blockbuster drugs. The legislation also continues a five-year "sunset" policy for a related rule that gives FDA authority to require pediatric studies under certain conditions, instead of making that authority permanent.
FDA HAS LEEWAY
Manufacturers that violate REMS requirements or fail to complete post-approval studies could be hit with new fines. And the final bill includes language that could undermine FDA authority to pre-empt state laws imposing different disclosure and labeling policies than the federal agency, a very troubling provision for industry as well as FDA. It will take months to unravel all the details in this 400-plus-page bill (available at http://energycommerce.house.gov/), which will keep a lot of lawyers and policy analysts very busy.
In this second part of a two-part podcast episode, Managed Healthcare Executive's Managing Editor Peter Wehrwein spoke with CeCi Connolly and Margaret "Meg" Murray about Medicare Advantage utilization and challenges, highlighting proposed CMS payment cuts and prior authorization issues.
Listen
In this first part of a two-part podcast episode, Managed Healthcare Executive's Managing Editor Peter Wehrwein kicks off our new podcast series "DC Roundtable," with guests Margaret "Meg" Murray, CEO of the Association of Community Affiliated Plans, and member of MHE's Editorial Advisory Board, and CeCi Connolly, president and CEO of the Alliance of Community Health Plans, for a discussion on healthcare policy issues.
Listen
2024 Emerging Leaders in Healthcare — Submit For a Chance to Be Featured in MHE's August Issue
March 26th 2024MHE Editors are seeking diverse healthcare professionals from different backgrounds and healthcare sectors, with individual interests. Eligible candidates are early or mid-career leaders with less than 10 years of experience. Award winners will enjoy complimentary passes to the PBMI Annual National Meeting in Orlando, Florida, from Sept. 4-6. Additional perks include a feature in our August issue, a subscription to MHE and more!
Read More