FDA Seeks Increased Use of Generic Drugs

In a new blog post, FDA Commissioner Scott Gottlieb, MD, discusses how the agency is seeking to increase the uptake of generic drugs to combat high drug costs.

Many patients pay increasingly high prices for prescription drugs to treat various conditions. Recently, there has been outrage over costs for drugs such as insulin, EpiPen, and cancer drugs.

Although the FDA does not control drug pricing, there are steps the agency can take to increase the competition in the market and drive down drug costs, according to the article. One approach is to facilitate the approval of lower-cost generic drugs.

Dr Gottlieb reports that the healthcare system has saved more than $1.67 trillion over the past decade through the use of generic drugs. The savings are apparent for patients at the pharmacy who may have been spending a significant portion of income on a prescription, but now pay a fraction of the price due to the availability of a generic option.

The FDA suggests that helping more safe, effective generic drugs receive approval—after patent and exclusivity periods have ended—could generate even more substantial savings, according to the article.

The current scientific and regulatory obstacles faced by generic drugs may delay or prevent patient access to a lower-cost therapy, Dr Gottleib wrote.

While developing innovative prescription drugs are needed, access to lower-cost alternatives is crucial for patient health and savings, according to the article.

Now, the FDA is developing a Drug Competition Action Plan and holding a meeting to discover which rules are being used to create obstacles to generic access.

The agency understands that sometimes FDA regulations are sometimes harnessed in a way to delay generic approvals, and they are actively looking to revise the rules.

An example of the tactics used are the unavailability of branded drugs for comparative testing. For generic drug development, a manufacturer requires 1500 to 3000 doses of the branded drug. In some cases, branded companies use regulatory strategies or techniques to block the generic companies from accessing testing samples, according to the article.

This problem is also seen for limited distribution branded drugs. Branded sponsors may use the limited distribution networks to prevent generic manufacturers from obtaining samples of the drug.

Dr Gottlieb also highlighted that some branded manufacturers may use statutory default requirements to have 1 Risk Evaluation and Mitigation Strategy (REMS) for branded and generic versions of a drug to block generic versions from emerging. This may lead to negotiations over the implementation of the shared REMS, and could delay the generic launch.

The FDA is seeking to address the actions and increase appropriate competition, according to the article. In addition to the public meeting, the agency will also be exploring policy changes. Some steps may be taken by the FDA, while others may require working with other government agencies.

As initial elements of the plan are implemented, Dr Gottlieb said that the agency will provide updates regarding how the work is addressing the issues patients face when purchasing costly prescription drugs.

The goal of the FDA is to increase access to safe and effective generic drugs that will help patients’ lower healthcare costs, according to the article.

“Over the past 5 years our generic drug program staff has evolved and grown remarkably, while implementing the first generic drug user fee program,” Dr Gottleib concluded. “The staff has demonstrated that they can rise to new challenges and they have my full support. Their hard work will serve as a strong foundation for the program as it moves forward. I want the policy framework they operate under to be as efficient, fair, and robust as the review program that they’re operating."