The FDA’s Streamlined Drug Approval Process: What You Need to Know

Major news from 2018 was the FDA’s announcement of upcoming changes to  the processes of the drug review office. Included in the modernization, per a written statement[1] from the FDA Commissioner Scott Gottlieb, is to provide FDA scientists and medical officers the opportunity to become “thought leaders”[2] in their fields.

The proposals for change include both structural and functional changes. Perhaps the largest change would be the development of a common review template that is built with collaboration in mind. According to the Commissioner, the proposed changes are expected to speed up the approval process for inexpensive generic medications, providing an incentive for second, third, or fourth wave drugs to enter the market.

Among the structural changes, the FDA is considering the creation of therapeutic-specific divisions that would enable specialized focus in discrete areas of medicine. This change would provide increased scientific leadership to academic, industry and patient groups. The FDA is predicting that the new plan will improve efficiency by at least 20%.

The relationship between safety and speed

Not surprisingly, skeptics[3] of the FDA’s decision to streamline processes and prioritize speed have raised concerns about the long-term safety risks inherent in the shorter timelines. In a piece from the New York Times[4], it was argued that efforts to speed a drug to market lower the standard of decision making on the safety and efficacy of the treatment. The commentary’s assertion was that the FDA should prioritize only those drugs with proven long-term benefits in at least two successful clinical trials, which would significantly reduce the risk of false positives.

The FDA maintains that a faster drug review process will be critical to encouraging innovation, and ensuring that breakthrough treatments make it into the hands of the patients who need them. Scott Gottlieb pointed to cancer patients in particular, who do not want to wait three years in order to access a potentially life-saving treatment.

In order to properly assess the increasing number of drugs in future accelerated timeframes, the Office of New Drugs will need to be overhauled. A large part of the overhaul will encourage focused reviews and systems that will increase the efficiency and consistency of the oversight process. 30 specific review divisions will now have nine as opposed to five drug review offices.

Communications challenges abound

As an increasing number of new drugs hit the market in the coming years, establishing an effective communications strategy for each new treatment will become vital; identifying and communicating the key differentiating benefits to stakeholders will be critical to gaining market share.

The medical writing and content development experts at Six Degrees Medical have decades of experience working in an ever-changing regulatory environment. Six Degrees Medical’s skilled team is uniquely equipped to support the pharmaceutical industry and help develop communications strategies aligned with regulatory requirements and company philosophy.

For more information on how Six Degrees Medical can support your organization’s communication efforts following the FDA’s upcoming process changes, contact one of our team members today at +1 647 725-0073.

[1] FDA, “Statement from FDA Commissioner Scott Gottlieb, M.D., on Propose Modernization of FDA’s Drug Review Office”, https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609647.htm

[2] Copyright Clearance Centres, “How the FDA Plans to Modernize New Drug Review Process”, http://www.copyright.com/blog/fda-new-drugs-review-process/

[3] Pharmexec.com, “Regulatory Innovation Generates Breakthroughs”, http://www.pharmexec.com/regulatory-innovation-generates-breakthroughs

[4] New York Times, “Easier Drug Approval Isn’t Cutting Drug Prices”, https://www.nytimes.com/2018/06/08/opinion/drug-approval-cutting-prices.html?rref=collection/sectioncollection/opinion-editorials&action=click&contentCollection=editorials&region=stream&module=stream_unit&version=search&contentPlacement=1&pgtype=s

January 10th, 2019|Categories: Blog|