FDA to improve generic drug review to enhance competition, promote access and lower drug prices

The FDA has announced more steps to encourage generic competition as part of its three-components Drug Competition Action Plan, by which it expects to promote competition this year, to help reduce drug prices and improve access to medicine for Americans.

So far, the goal was to reduce gaming by branded companies that can delay generic drug entry; resolve scientific and regulatory obstacles that can make it difficult to win approval of generic versions of certain complex drugs; and improve the efficiency and predictability of the FDA’s generic review process to reduce the time it takes to get a new generic drug approved and lessen the number of review cycles undergone by generic applications before they can be approved.

The new steps we’re announcing today go toward achievement of this third goal.

The FDA said that it will release two documents today that together will streamline and improve aspects of the submission and review of generic drug applications (known as Abbreviated New Drug Applications, or ANDAs). The first, Good ANDA Submission Practices” – should point out usual recurring deficiencies that happen in generic drug applications that may lead to a delay in their approval. As the FDA Commissioner Scott Gottlieb, said in the statement, one key reason why generic approvals are delayed is that many applications need to undergo multiple cycles of review.

“While often this is because the application lacks sufficient scientific evidence to support approval, there are also many times when the FDA must ask applicants for additional information in order to determine that the requirements for approval have been met, even if an application meets the threshold requirements for filing,” the commissioner said. He pointed out that it currently takes on average about four costly and inefficient cycles for an ANDA to reach approval. One of the reasons is missing information.

Additional work can delay the entry of generic competition, Gottlieb pointed out and said that one of the FDA’s key goals in 2018 is to reduce the number of review cycles. This can be done by helping applicants avoid these common deficiencies that lead to review delays and application cycling.

Among other things, the new MAPP establishes that when the FDA determines that an ANDA cannot be approved in its current form, reviewers should provide more detail to generic applicants to explain the deficiencies with the application; outline details on how this information should be provided; and provide more detail, when available, on the additional information that the generic applicant must provide to the agency to support an approval decision during the next application cycle.

The goal is to make sure that generic drug makers are made fully aware of the problems that are delaying the approval of their application and understand how to fix them.

“This new MAPP does not alter the important Generic Drug User Fee Amendments IIreview goals or program enhancements, nor does it alter the regulatory requirements for ANDA approval. Rather, the goal of the MAPP is to guide FDA staff to help ensure we work more efficiently with the goal of improving review times.”

Record breaking months

In 2017, the FDA has had several record-breaking months for the number of generic medicines approved in a single month, most recently in November, when the highest number of generic medicines were approved in the FDA’s history. Also, the commissioner said that for the full year, the FDA has approved a record number of generic drugs, including first generics, high-priority medications, and drugs meeting vital public health needs. “In addition to the increase in the volume of drugs being approved, the average number of review cycles needed to approve each eligible application is decreasing. The FDA took action on more applications in the last six months of 2017 than any other six-month period in FDA history,” he said.

In 2018 the FDA will try to improve the practices to help guide industry to make sure their generic drug applications can be acted upon as efficiently as possible. Gottlieb gave an example of planned actions. He said. “For example, we’ll be building on our initiatives to accelerate generic entry of complex generics, which include medicines like metered dose inhalers used to treat asthma, as well as some costly injectable drugs, which are sometimes hard to copy.”

To remind, the Trump administration in March has budgeted over $2 billion for 2018 in fees to be collected by the U.S. Food and Drug Administration from industry, twice as much as in 2017.

By the beginning at the year the US president also called for reducing prices, and has been called a populist. However, as the FDA has said, there are some moves that might be leading to reducing prices.