What Pharmacists Should Know About the FDA’s DCAP for Generic Drug Access

The FDA’s Drug Competition Action Plan (DCAP) helps patients get access to generic drugs by removing barriers.

The DCAP was created in 2017 to encourage market competition for generic drugs and help to enhance the generic drug review process so that patients have access to these medications at affordable prices. The following three areas have been the main focus under the plan: improving the efficiency of the generic drug development, review, and approval process; streamline regulatory requirements for generic drugs while maintaining evidence-based medicine practices; and close loopholes that enable brand-name companies to participate in “gaming” to delay generic drug approvals. Pharmacists can assist patients with obtaining affordable generic drug products.

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DCAP Latest Updates

The FDA updated the list that identifies all drug products for which the FDA has received a reference listed drug (RLD)inquiry. This list includes the RLD sponsor, drug product, and number of inquiries the FDA has received. Generic companies often times have trouble purchasing samples of certain brand products needed to support approval of a generic drug. Unfortunately, this can impede the generic drug development process which delays timely access of these medications to patients. These changes will make it easier for generic companies to conduct bioequivalence studies that generally need 1,500-5,000 units of the RLD. The FDA has also issued guidance on addressing the review of citizen petitions so that there is less of an impact on pending generic drug approvals. These new measures will also help to prevent “gaming” and offer a more efficient way for generic drugs to enter the market.   

DCAP Main Focus Areas

According to a study from the Kaiser Family Foundation, 79% of individuals believe the cost of prescription drugs is too high and those taking four or more medications have the most difficulty affording them. Additionally, 88% of Americans favor making it easier for getting generic drugs to the market. As part of the DCAP, the FDA has taken measures to enhance the generic drug review and approval process, which includes improving the quality of abbreviated new drug applications (ANDAs) submitted.

Since complex generic drugs are more difficult to develop, they generally experience less competition than other medications. This may lead to higher drug costs and less affordability for patients who need these products. The FDA provided a workshop on complex generic drug product development in September as guidance on introducing more of these medications to the marketplace. The topics covered at the workshop include bioequivalence study approaches, scientific and regulatory advances for generic topical and transdermal drug development, pre-ANDA program updates, and injectable, orally-inhaled, and nasal drug products.

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According to the 2018 Annual Report of the Office of Generic Drugs, over 1,000 generic drugs were approved, with record breaking approvals in October and November. First generics (generic drug approvals for brand medications that had no FDA-approved generic) made up almost 10% of the 2018 drug approvals. Additionally, of the first generics, 18% were for complex generic drugs. These results demonstrate that more generic drugs are available through the DCAP efforts.