- As 2017 came to a close and the New Year begins, the Food and Drug Administration has launched two new guidances which aim to improve the agency’s interactions with industry to make drug development "more informed and efficient."
- The aim of the final guidance on communication is to improve the transparency and timeliness of communications between drug developers and the review staff at the FDA, building in advice and science-based feedback.
- The draft guidance on formal meetings with the FDA on Prescription Drug User Fee Act products has been created to help these meetings become more consistent, improving the speed and efficiency of drug approvals.
FDA Commissioner Scott Gottlieb has only been in post since May 2017, but he has already made some key changes. In 2017, the FDA beat its 2015 approval record for approvals of New Molecular Entities, approving a total of 46. Gottlieb has struck a positive tone about the cost-saving potential of biosimilars and generics, and is developing guidance to make it easier to bring generic drug-device combinations to the market. He has also issued guidance on 3D printing in drug development. Gottlieb's other focuses since taking up the role have included opioid addiction and abuse-deterrent opioid generics, addressing drug pricing and increasing the FDA's oversight of homeopathic drugs.
These new guidances are the first outcomes from the FDA's goals for 2018, set out at the end of 2017. These included targeting nicotine addiction, improving food and drug safety, and modernizing standards by creating better defined and more efficient regulations, such as increased acceptance of electronic submissions, and outdated inspection provisions.
"The rising cost of drug development has an impact on the price of medicines and affects patient access to health care. Set against the major promise offered by a new generation of more targeted medicines, we must look for ways to make the drug development process more efficient to make sure patients are able to access breakthroughs in a timely, affordable way," said Gottlieb.
The final guidance on "Best practices for communication between IND sponsors and FDA during drug development" plans to improve communication between drug developers submitting investigational New Drug Applications and the FDA staff carrying out the reviews. The plan is to ensure that communications are timely and interactive, that the scope and frequency of advice that companies can seek is clearer, and that the response times are more transparent.
The draft guidance, "Formal meetings between the Food and Drug Administration and sponsors or applicants of PDUFA products," outlines procedures for the timely and effective conduct of these types of meetings.
"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. This early and more thorough engagement can help innovators meet the FDA’s science-based requirements more effectively, meaning product developers will avoid costly delays that can unnecessarily impede access to beneficial new medicines," said Gottlieb.