FDA has sprinted out of the starting blocks the past few months by taking major steps toward improving the efficiency of generic drug approvals. Back in June, they announced the Drug Competition Action Plan. As part of that effort, they held a public meeting to solicit input on places in which FDA rules - including standards and procedures related to generic drug approvals - are being used in ways that may create obstacles to generic access, instead of ensuring the healthy competition Congress intended.
“We know that sometimes our regulatory rules might be ‘gamed’ in ways that may delay generic drug approvals beyond the time frame the law intended in order to reduce competition,” said Dr. Scott Gottlieb, FDA Commissioner, in an FDA blog. “We are actively looking at the ways our rules are being used and, in some cases, misused.”
Examples of such gaming include the unavailability of certain branded products for comparative testing. To perform the studies required to develop a generic alternative to a branded drug, a generic sponsor needs about 1,500 to 3,000 doses of the originator drug, FDA explains. In some cases, branded companies may be using regulatory strategies or commercial techniques to block a generic company from getting access to testing samples. There are also problems accessing testing samples when branded products are subject to limited distribution.
The FDA has been looking at policy and program changes to address these issues. They’re also going to work with the Federal Trade Commission in identifying and publicizing practices that the FTC finds to be anti-competitive. Of course, it is the FTC’s responsibility to prevent anticompetitive business practices. But Congress set out certain laws that are meant to strike a balance between pharmaceutical innovation and access to lower cost generic products, FDA says, and they have a responsibility to enforce those laws.
Another goal of the Action Plan is to make it easier to bring generic competition to a category of branded drugs known as complex drugs, which comprise high-cost medicines like metered dose inhalers used to treat asthma, as well as some costly injectable drugs. FDA says those medicines generally have at least one feature that makes them harder to “genericize” under traditional approaches. Thus, those drugs can face less competition. They say in some cases, costly, branded drugs that are complex drugs have lost their exclusivity, but are subject to no generic competition.
“Because brand-name versions of complex drug products are often higher-priced than many other brand name drugs, any steps we can take to encourage the development of generic competitors to complex drugs will have an outsized impact on access, and prices,” says Gottlieb.
FDA says manufacturers of complex generic drugs face many challenges in developing their products and demonstrating that they meet approval requirements for generic drug applications (ANDAs), including establishing that they are bioequivalent to and have the same active ingredient as the brand-name drug. Thus, they are taking new steps to support the development of high-quality ANDAs for complex generic drugs.
First, they are issuing a draft guidance to assist ANDA applicants in creating and submitting pre-ANDA meeting requests, including meeting package materials, so FDA can give better advice to sponsors of complex generic drugs. Second, they’re issuing a draft guidance to help applicants determine when submission of ANDAs for certain complex products, known as peptides, would be appropriate.
“We’re doing all of this without sacrificing the scientific rigor of the process one bit,” Gottlieb adds. “A central aspect of our approach, and our efforts to spur innovation and generic competition, is focused on adopting more rigorous and sophisticated science, including sophisticated quantitative methods and computational modeling, in drug development, evaluation and review.”
Over the last decade alone, competition from generic drugs has saved the health care system about $1.67 trillion. The FDA sees even greater cost savings as they reach the finish line - delivering more safe, effective generic drugs to market sooner and lowering health care costs.