Industry and consumer groups call for improved review practices, transparency in PDUFA VIII

Industry and consumer groups are calling for the US Food and Drug Administration (FDA) to fix inconsistent review practices, hold more face-to-face meetings, and provide greater transparency in the drafting of commitment letters in the next iteration of the Prescription Drug User Fee Act (PDUFA VIII). Patient groups said they feel shut out of the negotiations and want that to change.

These recommendations were in response to FDA’s call for comments on the user fee program’s reauthorization ahead of a public meeting last month; the current the program (PDUFA VII) expires in September 2027. (RELATED: Makary suggests lower PDUFA fees as reauthorization process begins, Regulatory Focus 20 August 2025)

In its notice, FDA requested that stakeholders assess what current features of PDUFA should be reduced or discontinued to ensure the continued efficiency of the drug review process and if any changes are necessary to the current fee structures. The deadline for providing public comment was 14 August.

FDA received 62 responses, including comments from the Pharmaceutical Research of America (PhRMA) and Biotechnology Innovation Organization (BIO), which will represent the pharmaceutical industry in the negotiations. Respondents also included non-profit and consumer groups, who were more pointed and direct in their comments on the user fee program.

Transparency

Biocom California said that to improve PDUFA, there should be greater transparency and early discussions with industry on when inspections are needed. Biocom California is a nonprofit group that represents 1,400 members of California’s life science sector, which includes biotechnology, pharmaceutical, medical device, genomics, and diagnostics companies.

The group stated that “there is a need for increased transparency and earlier discussions about inspections to occur between the agency and sponsors in order to streamline inspection processes for both parties and to ensure that sites are producing high-quality, GxP work.”

The PDUFA VII commitment letter outlines the FDA's goal to complete all Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) inspections within six months for priority applications and within ten months for standard applications. This timeline allows for an additional two months at the end of the review period to address any deficiencies identified during the inspections. However, Biocon has stated that two months is insufficient time to resolve issues found in inspections.

The group said that “inspections conducted near the end of the review cycle do not allow sponsors adequate time to comprehensively address issues.”

The Patient, Consumer, and Public Health Coalition expressed the need for more transparency in the drafting of the PDUFA commitment letters. The coalition includes 13 groups, including the Cancer Prevention and Treatment Fund, Doctors for America, Generation Patient, Jacob’s Institute of Women’s Health, and Healthy Americas Foundation.

The coalition wrote that “The PDUFA VII commitment letter was 71 pages long and included many requirements for the FDA. All PDUFA Commitment letters have been negotiated behind closed doors; patients, consumers, public health advocates, and health professionals have had no access. We can neither attend the meetings nor watch them.”

The coalition further noted that PDUFA is primarily focused on “what industry wants, not on what other stakeholders need.”

Inconsistent review practices

Biocom stated that, in its reviews, FDA should ensure consistency among reviewers across different disciplines.

The group wrote that, “In general, many divisions within the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) employ high-quality review practices that guide and assist sponsors through the regulatory process. However, sponsors have occasionally experienced inconsistent review practices between some CDER and CBER divisions, which could be attributed to varying resources, differences in staff training, staffing levels, employee attrition, and turnover. New reviewers often lack the necessary experience to review certain specialized drug products, which pose unique regulatory challenges.”

Biocom also urged the agency to hold more face-to-face meetings. The company wrote that “in recent years, sponsors have received an increasing number of written responses (WROs) instead of face-to face (FTF) meetings to address and resolve submission issues. In certain instances, a FTF meeting would be more helpful for both the sponsor and reviewer to resolve and discuss issues in real-time.”

Calls for non-animal testing

The Physicians Committee for Responsible Medicine urged the FDA to bolster the use of new approach methodologies (NAM) to reduce animal testing for new drugs.

“Through PDUFA VIII, we urge the FDA to enhance the use of new approach methodologies (NAMs), including advanced in vitro systems and computational modeling, as regulatory decision tools in drug development and review…. Traditional animal studies contribute to inefficiencies in drug testing. The vast majority of drugs that appear successful in animal studies later fail in humans because they are unsafe for humans or do not work.”

PhRMA and BIO praise the program, offer little specific criticism

PhRMA and BIO expressed broad support for the program and raised limited specific criticisms of it.

PhRMA said that “for more than 30 years, PDUFA has helped the FDA fulfill its central mission – to help protect and promote the public health by ensuring the safety, efficacy, and security of drugs – by allowing the Agency to keep pace with the rapid increase in the number and complexity of innovative drugs and biologics entering the review pipeline.”

The group said that PDUFA VIII could be improved by focusing on facilitating first cycle review of new applications and helping FDA optimize available staffing “by supporting new efficiencies in the human drug review program and streamlining regulatory review processes.”

BIO said its objectives for PDUFA VIII are to “prioritize core review activities to ensure safe and effective biotech innovations reach patients faster, ensure FDA meets its review activity performance commitments, increase predictability of the PDUFA review process and financial structure, and improve FDA communications, transparency, and accountability.”

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Industry and consumer groups call for improved review practices, transparency in PDUFA VIII

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