FDA to Provide Earlier, Better Advice to Drug Developers


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 The draft guidance offers recommendations on formal meetings between the agency and drug developers, and the final guidance explains the best practices for communication between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.

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 me.

“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.

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