Lawmakers Considering Renewal of User Fees for FDA Approval Processes
During a House hearing on Wednesday, seven health care industry representatives will ask lawmakers to quickly renew FDA's authority to collect user fees from pharmaceutical and medical device companies for its approval processes, according to testimony documents released ahead of the hearing, CQ Today reports.
The House Energy and Commerce Health Subcommittee hearing is the first of three congressional hearings scheduled this month on the Prescription Drug User Fee Act, which expires on Sept. 30. The seven witnesses will seek the panel's approval of an agreement between FDA and stakeholders to reauthorize PDUFA through fiscal year 2017 and increase user fees by 6% (Ethridge, CQ Today, 1/31).
According to CQ HealthBeat, FDA Commissioner Margaret Hamburg, who also will testify at Wednesday's hearing, is expected to announce details of an agreement with the medical device industry to raise user fees by 3% annually.
Preliminary details of the agreement indicate that it will address:
- Concerns about the slow medical device approval process at FDA;
- Manufacturers' response times to additional data requests; and
- Future analyses by independent consulting groups of FDA's review process (Adams, CQ HealthBeat, 1/31).
Also at the hearing, Allan Coukell -- director of medical programs at the Pew Health Group -- is expected to suggest that FDA be allowed to reject products from facilities that refuse inspections, particularly those that are located abroad. Coukell also will recommend that FDA use third-party entities to conduct those inspections or to rely on qualified foreign regulatory bodies' inspections (CQ Today, 1/31).
Lawmakers Likely To Introduce Measures To Address Drug Shortages
In related news, lawmakers could include provisions in legislation to fund FDA that address the ongoing shortage of essential life-saving medications, Reuters reports.
Debate on the funding legislation is expected to be a part of the hearings on the reauthorization of PDUFA. A congressional aide also noted that the PDUFA reauthorization bill could serve as a "vehicle" for the drug shortage measures.
Two bills designed to force drugmakers to notify FDA about looming drug shortages have stalled in Congress, while a third bill (HR 3839) -- by Reps. John Carney (D-Del.) and Larry Bucshon (R-Ind.) -- was introduced on Tuesday.
The measure would require FDA to accelerate its application review process for drugmakers that want to change or increase production to address a drug shortage. It also would require the Drug Enforcement Agency to increase its quota for specific controlled substances if they are necessary to address a shortage (Yukhananov, Reuters, 1/31).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.