What the FDA Wants Pharmacists to Know About Generic Drugs


Drug Topics recently spoke with the FDA about the role pharmacists can play in patient education.

FDA Building

Demand for generics and biosimilars is growing. In 2017, generic drugs generated $265 billion in savings. New biosimilars could play a major role in increasing competition and driving down costs. 

Drug Topics spoke with officials from the FDA’s Office of Generic Drugs (OGD) and from the Therapeutic Biologics and Biosimilars team (TBB) about how the agency is helping accelerate generics to market, and the role pharmacists play in educating patients about the safety, effectiveness, and quality of generics and biosimilars.

Related article: Why Health Systems Are Making Their Own Generics

DT:How is the FDA accelerating generics to market? What are some of the obstacles? What does the generic market look like going forward into 2019 in terms of approvals?

OGD: FDA plays a critical role in increasing access to safe, effective, high-quality generic drugs to the American public. While FDA doesn’t have a direct role in when a product is marketed after approval or drug pricing, when more than one generic version of a drug is approved and marketed, it spurs competition and facilitates affordable options for consumers. Providing access to generic medicines is a top priority at FDA. 

The FDA Reauthorization Act of 2017 includes the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II) and provides the generic drug program with increased resources to help promote more robust generic drug competition. The GDUFA II Commitment Letter represents the agreement reached by FDA and the generic pharmaceutical industry, along with discussions with public stakeholders. This was mandated by Congress. Under GDUFA we have taken steps to enhance access to generic products. We continue to review and enhance our Prioritization of the Review of Original Abbreviated New Drug Applications (ANDAs), Amendments, and Supplements Manual of Policy and Procedures to ensure we are working towards the utmost public health priorities. 

The GDUFA performance goals are intended to reduce the number of review cycles and increasing first-cycle approvals to potentially speed access to generic drugs. A highlight of the Commitment Letter is the new pre-ANDA program for complex generic drug products, which have been more challenging to develop and can lack generic competition. The goal of the pre-ANDA program is to clarify regulatory expectations for prospective applicants early in product development, assist with more complete submissions, and promote a more efficient and effective ANDA review process. 

One obstacle preventing generic competition is the gaming that delays generic drug approvals and extends brand monopolies beyond what Congress intended. Such gaming includes failing to provide certain branded products for comparative testing whereby generic drug developers experience problems accessing testing samples when branded products are subject to limited or restricted distribution. To help address this issue and provide transparency, FDA has posted a list identifying all drug products for which FDA has received an inquiry related to limited distribution of the marketed reference listed drug.

Related articles: FDA Assists Generic Drugmakers with New Guidances

These initiatives represent some of the activities under the Commissioner’s Drug Competition Action Plan that support the agency’s commitment to ensure that the American public has timely access to safe, effective, and affordable medicines.

While FDA has no regulatory authority over what products are marketed and when, the agency believes that the processes introduced though GDUFA II and the Drug Competition Action Plan will help to reduce approval times and increase the availability of generic drugs.

DT: As more generic drugs enter the market, what role can pharmacists play in educating healthcare providers about using generics? How are pharmacists positioned for this task? How does the FDA disseminate information/reports to the pharmacy community on generic drug development and review?

OGD: FDA believes that pharmacists play an important role in educating patients about the medicines they are prescribed and on safety, effectiveness, and quality of generic medicines.

Related article: Why Generic Drug Prices Are Dropping

FDA routinely provides educational materials for pharmacists and healthcare providers at our website.

The FDA regularly updates and shares information on generic drugs via our website. The pharmacy community can also refer to the Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) which identifies drug products approved on the basis of safety and effectiveness by FDA under the Federal Food, Drug, and Cosmetic Act and related patent and exclusivity information. The Orange Book is a resource that is widely-used by pharmacists and prescribers to identify generic drugs that are substitutable for various brand-name medicines. It is also available as a mobile app that can be downloaded from the App Store and Google Play.  

We also provide email updates on generic drugs including new guidances for industry, noteworthy approvals, and other important information on generic drug development and review to individuals who sign up to our RSS feed. Interested parties can go to https://www.fda.gov/aboutfda/contactfda/stayinformed/rssfeeds/default.htm, and receive email updates.


DT: What is the status of biosimilars in regard to lowering healthcare costs?

TBB: While the FDA doesn’t regulate drug prices, we are charged by Congress to advance policies that maintain a balance between encouraging and rewarding medical innovation and facilitating robust and timely market competition. Robust competition expands patient access to more affordable products like generics and biosimilars. Millions of American patients may benefit from increased access to lower-cost, high quality biosimilar products.

As Commissioner Gottlieb recently stated during his speech at the Brookings Institution to announce the Biosimilar Action Plan (BAP), “enabling a path to competition for biologics from biosimilars is a key to reducing costs and to facilitating more innovation.” The FDA has approved 11 biosimilars to date. 

Gottlieb also outlined some of the obstacles biosimilars face in the marketplace, such as our current payment system, litigation, and rebating practices, but he also outlined four key FDA strategies in the BAP to accelerate biosimilar competition: 

Related article: FDA Promises Easier Generic Drug Applications

  • Improving the efficiency of the biosimilar and interchangeable product development and approval process.
  • Maximizing scientific and regulatory clarity for the biosimilar product development community.
  • Developing effective communications to improve understanding of biosimilars among patients, providers, and payers.
  • Supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay market competition to follow-on products.

The FDA will continue to advance new regulatory science tools that ensure patients benefit from rapid advances in science and technology that biological products can offer.DT: What makes pharmacists well positioned for this task?

TBB: Pharmacists interact with both doctors and patients, making them an integral part of the exchange of information between both the prescriber and the patient. Pharmacists are also uniquely positioned for this task because of their specialized knowledge and experience about pharmacology and therapeutics, including the properties of drugs, pharmacokinetics, adverse drug reactions, and drug interactions. 

DT: What do you see as the biggest challenge for the healthcare industry as the new forms of drugs are introduced?

TBB: Biological products have revolutionized treatments for many serious and life-threatening conditions, but it can be financially difficult for patients when the right treatment for their condition or disease is a high-cost biological product. With the cost of prescription drugs an ongoing concern in healthcare, the emergence of biosimilars offers more treatment options for patients, as well as much-awaited market competition that can potentially reduce costs for patients with serious medical conditions. 

Related article: Generic Cholesterol Meds a Boon for Patients

DT: What else might be important for our readers to consider regarding biosimilars?

TBB: All FDA-approved biological products, including reference products and biosimilar products, undergo a thorough evaluation so that patients can be assured of the efficacy, safety, and quality of these products.  It is important for pharmacists to understand that FDA undertakes a comprehensive evaluation to ensure that biosimilar and interchangeable products meet the respective rigorous standard for approval. Healthcare providers and patients can expect that there will be no clinically meaningful differences between taking a reference product and a biosimilar when these products are used as intended. As with other drug products, healthcare providers should review the prescribing information in the labeling for detailed information about the approved uses.

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