Drug Developers to Get Better, Earlier Advice From FDA

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By Bronwyn Mixter

The FDA is looking to enhance its communications with drug sponsors early on as a way to lower the cost of drug development.

If the cost of developing a drug is high, then the drug’s price also will be high. The Food and Drug Administration is trying to make the drug development process more efficient so patients can access new medicines in a timely, affordable way, FDA Commissioner Scott Gottlieb said in a Dec. 28 statement.

As part of its efforts, the FDA Dec. 28 issued a draft and a final guidance. The draft guidance offers recommendations on formal meetings between the agency and drug developers, and the final guidance explains the best practices for communication between investigational new drug application (IND) sponsors and the FDA. Before starting a clinical trial, a drug developer must submit an IND to be allowed to administer an investigational drug to humans.

“By engaging with product developers early, often before clinical research is underway or an application is submitted to the agency, the FDA’s scientific experts can share important advice on the proper design of clinical trials and other aspects of the development and regulatory process,” which can help innovators avoid costly delays, Gottlieb said.

Praise for FDA’s Action

The guidance documents “double down on FDA’s commitment to partner with companies early and often in the drug development process,” Nathan A. Beaver, an attorney with Foley & Lardner LLP in Washington, told Bloomberg Law in an email.“Guidance on best practices and procedures for collaborating during drug development should be welcomed by industry,” Beaver said. “Commissioner Gottlieb’s engagement on this issue is encouraging and demonstrates his continued commitment to working with industry to increase the efficiency of the process.”

Beaver represents manufacturers whose products and activities are regulated by the FDA. He also is a Bloomberg Law advisory board member.

Draft Guidance

Drug sponsors or applicants can request formal meetings with the FDA to discuss their products. FDA review staff and sponsors adhere to the meeting management goals established by the Prescription Drug User Fee Act (PDUFA). PDUFA allows the FDA to collect user fees from drug manufacturers, and in return, the agency commits to performance goals.

The draft guidance, Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products, discusses good meeting management practices and describes standardized procedures for requesting, preparing for, scheduling, conducting, and documenting formal meetings.

The Pharmaceutical Research and Manufacturers of America (PhRMA) is still reviewing the draft guidance, but appreciates the FDA taking steps to fulfill its PDUFA commitments, Andrew Powaleny, the group’s director of public affairs, told Bloomberg Law in a Dec. 28 email. “We further recognize the important role communications and meetings play between the FDA and sponsors during the drug development and review process,” he said.

Comments on the draft guidance are due March 29, 2018 (Docket No. FDA-2017-D-6530).

Final Guidance

The final guidance, Best Practices for Communication Between IND Sponsors and FDA During Drug Development, describes the scope of appropriate interactions between FDA review teams and these sponsors.

The guidance also outlines what types of advice sponsors may seek from the FDA in pursuing their drug development programs; explains when to expect FDA responses to sponsor inquiries; explains best practices and communication methods to facilitate interactions between review teams and sponsors; and includes expectations on appropriate methods and frequency of such communications.

This guidance is the final version of a draft guidance issued on Dec. 9, 2015.

Notices announcing both guidance documents will be published in the Dec. 29 Federal Register.

To contact the reporter on this story: Bronwyn Mixter in Washington at bmixter@bloomberglaw.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bloomberglaw.com

For More Information

The draft guidance is at http://src.bna.com/vik and the final guidance is at http://src.bna.com/vij.

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