US House Conducting User Fee Markup

US House Conducting User Fee Markup

May 15th, 2022 // 4:12 pm @

The House has been working this month on reauthorizing the FDA user fee program. Also, there are reports that FDA is looking into a new program to make it easier for pharmaceutical companies to develop drugs for rare diseases where there has been an unmet medical need.

Regarding the user fee markup, the House Energy & Commerce Health subcommittee is marking up the bill to reauthorize the user fee agreement. The legislation was released earlier this month after extensive talks between industry and FDA. The House had a unanimous vote last Monday, which allowed the subcommittee to advance the bill to the entire committee. Politico reports the full committee will look at the legislation early this week. The Senate is reportedly still putting together its version of the reauthorization bill.

Regarding the program for rare diseases, CDER is launching the Accelerating Rare disease Cures to speed the development of medicines that meet the need for rare diseases. The CDER effort is spearheaded by the rare diseases team at the Center. CDER says in the initial year, The ARC will center on boosting the external and internal partnerships with major stakeholders and will retain external drug experts to find solutions for the obstacles in rare disease drug development.

Also, the Center for Devices and Radiological Health or CDRH recently issued a public comment summary and details of changes it made to the MDUFA V agreement. That document spells out the revisions that the agency made to several provisions. One of the was adding performance goals for the TPLC or Total Product Life Cycle Advisory Program (TAP Pilot). There also are additions for postmarket safety and several other parts of the five-year agreement.

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