What New FDA Guidance Documents May Mean for Pharma
Brian Wu, MD, PhD
BRIAN WU, MD, PHD
Back in October, the Food and Drug Administration (FDA) published a series of documents regarding Abbreviated New Drug Applications (ANDAs) for the “genericization” of drugs, with a particular emphasis placed on simplifying the process by which companies can produce generic versions of complex drugs. These publications are part of a larger campaign by the FDA to increase competition on the drug market, reduce overall costs, and streamline the process by which generic drugs reach the market. This could have a strong impact on the pharmaceutical industry, which already faces stiff competition from generic competitors.
ANDAs: Their Importance and Controversy
The FDA defines an ANDA as a document that “covers data which is submitted to the FDA for review and potential drug approval of a generic drug product.” Once an ANDA has been approved, the successful applicant can then market the generic drug as a lower-cost alternative. This application is considered “abbreviated” because, generally speaking, animal and human trial evidence is not required. However, before an ANDA can be approved, the applicant must prove that their drug acts in the same manner as the reference product.
ANDAs have been the cause of some controversy and debate in the past. Industry leaders have called for shortening the time frame for the ANDA application process, according to Pharm Tech. The argument is that a more streamlined process for genericizing brand name drugs would help to both lower drug costs and to reduce the backlog of current ANDAs. Also, according to a report from the Regulatory Affairs Professionals Society (RAPS), ANDA guidelines released earlier in the year drew criticism from many generic drug companies and others in the industry because those guidelines established a two-month lead time to determine whether facilities will require inspections for the eight-month instead of the ten-month ANDA review. However, new ANDA documents just released appear to be trying to streamline the ANDA review process.
New Guidelines Issued by the FDA
The FDA published the following new guidance documents regarding ANDAs:
- ANDAs for Certain Highly Purified Synthetic Peptide Drug Products that Refer to Listed Drugs of rDNA Origin: Guidance for Industry. This document provides guidelines for applicants to help determine whether an application for a synthetic peptide drug product that refers to a previously approved recombinant DNA drug is eligible to apply for an ANDA.
- Formal Meetings between FDA and ANDA Applicants of Complex Products under GDUFA. This document describes an enhanced pathway by which applicants who wish to develop generic equivalents of complex drugs can meet with the FDA as part of the review process.
- ANDA Submissions Refuse-to-Receive Standards: Questions and Answers. In this documents, the FDA answers frequently asked questions about deficiencies in an ANDA that can lead the FDA to issue a refuse to receive (RTR) for the application. It also deals with a number of other important ANDA issues, such as bioequivalence, which is important for complex drugs.
- ANDA Submission Amendments to Abbreviated New Drug Applications under GDUFA. This document discusses how the new Generic Drug User Fee Amendment Reauthorization Act of 2017 (GDUFA II) applies to ANDA applications.
The FDA Speaks Out on the Importance of New Guidelines
Dr. Scott Gottlieb, the commissioner of the FDA, spoke out about the greater significance of these guidelines on the blog FDA Voice on the same day they were published. He begins by mentioning the previously established Drug Competition Action Plan that was meant to help bring more competition to the drug market. Part of the plan is aimed at closing loopholes that currently allow drug companies to forestall the genericization process. Gottlieb noted that one aspect of this action plan is to make it easier to bring generic complex drugs to market and that these new guidelines help support this goal.
Gottlieb also noted that it can be harder to develop generic equivalents to complex drugs, such as metered dose inhalers; as a result, complex drugs currently on the market can face little competition and be very costly to patients. However, Gottlieb said that the new policies “are aimed at ensuring that we provide as much scientific and regulatory clarity as possible with respect to complex generic drugs.” The commissioner also notes that the FDA has formulated these policies because complex drugs are important to both American patients and to the generic drug industry. And because these complex drugs can often carry a high price tag, efforts to develop generic equivalents can have a large impact on both accessibility and price.
The most important thing that the pharmaceutical industry should carry away here is that publications of these documents and the changes in ANDA applications in regards to complex drugs is considered to be only part of a larger strategy that the government intends to pursue over the next year. “Our announcements today are part of a broader effort by the administration to address the high and rising costs of drugs and in the coming months, we’ll advanced other policies aimed at enabling generic equivalents to complex drugs,” said Gottlieb
So, while the documents published are significant, what is even more important is the FDA’s overall plan to enable companies to genericize brand name drugs at a more expedient rate. This could lead to the pharmaceutical industry facing stiffer competition from these lower-cost drugs that might put stress on an industry that already faces a variety of economic challenges.
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