Generating Generics Faster

Drug pricing remains a hot topic in the industry, with consumers urging manufacturers and regulatory bodies to bring down the cost of medicines. Now, the FDA are planning to help the consumers’ cause. In a press release, FDA Commissioner Scott Gottlieb stated, (1) “Too many patients are being priced out of the medicines they need. While FDA doesn’t have a direct role in drug pricing, we can take steps to help address this problem by facilitating increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines.” The first steps toward this goal include speeding up the review of generic drug applications, and simplifying abbreviated new drug applications (ANDAs), allowing certain off-patent, off-exclusivity drugs to be accepted without prior discussion (2). The FDA are also teaming up with the Federal Trade Commission (FTC) to weed out the anti-competitive practices taking place in the market. Gottlieb’s press release said, “We know that sometimes our regulatory rules might be ‘gamed’ in ways that may delay generic drug approvals […] One such example of such gaming is the increasing unavailability of certain branded products for comparative testing […] in some cases, branded companies may be using regulatory strategies or commercial techniques to deliberately try to block a generic company from getting access to test samples.”

To gather more input on their plans, the FDA held a public meeting on July 18 and set out three main elements of its “Drug Competition Action Plan” (3), including:

• Looking for places where gaming of the system occurs, and changing rules where possible to ensure that the competition that Congress envisioned is taking place.
• Identifying potential scientific and regulatory obstacles that are hindering generic entry. The FDA aim to address these obstacles by ensuring that regulatory processes are in line with the most current advances in science.
• Focusing on the efficiency and throughput of the overall generic drug program, by ensuring that the FDA is evaluating new generic applications in an efficient manner.

Gottlieb also outlined the submission of a new generic drug user fee program (GDUFA) to Congress, and the creation of a new manual of policies and procedures (MAPP). The proposed GDUFA II intends to reduce the number of review cycles needed for ANDA approval, and increase the communication between the FDA and applicants to boost the chances of approval within one review cycle, while the MAPP outlines simplified documentation for policies and procedures. Despite these steps to streamline the generic review process, Gottlieb also added that, “this efficiency doesn’t mean lowering our standards.”

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References

1. FDA, “FDA working to lift barriers to generic drug competition”, (2017). Available at: http://bit.ly/2sqamP7. Accessed July 3, 2017. FDA, “FDA tackles drug competition to improve patient access”, (2017). Available at: http://bit.ly/2sWSLNj. Accessed July 10, 2017. FDA, “Opening remarks by Dr. Gottlieb for part 15 public meeting on generic drug competition”, (2017). Available at: http://bit.ly/2uBPAxN. Accessed July 20, 2017.

About the Author(s)

William Aryitey

My fascination with science, gaming, and writing led to my studying biology at university, while simultaneously working as an online games journalist. After university, I travelled across Europe, working on a novel and developing a game, before finding my way to Texere. As Associate Editor, I’m evolving my loves of science and writing, while continuing to pursue my passion for gaming and creative writing in a personal capacity.

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