Alerts and Updates

Transparency and Predictability - FDA Adds Useful Information to the ANDA Paragraph IV Certifications List

June 26, 2019

The additional information will also give the public better insight into the status of generic regulatory exclusivities and the potential future availability of lower-cost generic alternatives for specific drug products.

The U.S. Food and Drug Administration took another step to implement its Drug Competition Action Plan on June 18, 2019, by updating the information provided in the Paragraph IV Certifications List. The updated list will provide greater transparency regarding Paragraph IV certifications and potential exclusivities. That transparency will in turn lead to greater predictability for generic manufacturers regarding the potential timing of approval for their ANDAs and the potential degree of competition. The additional information will also give the public better insight into the status of generic regulatory exclusivities and the potential future availability of lower-cost generic alternatives for specific drug products.

Historically, the Paragraph IV Certifications List has included:

  • Drug name
  • Dosage form
  • Dosage strength
  • Reference listed drug (RLD) name and NDA number
  • Date on which the first substantially complete ANDA containing a Paragraph IV certification was filed

This limited insight left manufacturers and the public with incomplete information regarding the status of potential 180-day first-to-file exclusivities and future availability of lower-cost generic drug products. With the updated list, FDA is attempting to address that information gap and provide greater transparency. FDA’s new Paragraph IV Certifications List adds the following information:

  • Number of potential first applicant ANDAs submitted
  • Status of 180-day exclusivity decisions
  • 180-day decision posting date
  • Date of first approval of “first applicant” ANDA
  • Date of first commercial marketing
  • Expiration date of last qualifying patent

FDA intends for this additional information to allow generic drug manufacturers to make better-informed decisions regarding potential approval dates for ANDAs on file and also regarding potential competition for ANDA products yet to be developed.

The updated list will also be useful to the public by showing that FDA is efficiently approving applications without allowing “gaming” tactics by potential exclusivity holders. These tactics ultimately delay competition and are counter to the intent of the Hatch-Waxman regulatory scheme.

Updating the information provided on the Paragraph IV Certifications List ultimately furthers FDA’s Drug Competition Action Plan to enhance the efficiency of the development and approval of ANDA products and increase patient access to high-quality, low-cost generic drug products. Providing this additional information helps generic manufacturers predict when their ANDAs currently on file may be approved. It may also be a resource that manufacturers can use in product selection.

FDA’s increased transparency should ultimately build confidence in the agency’s commitment to promote timely access to high-quality, lower-cost generic drug products. Much of the information provided on the new list was available before by process of deduction from other publicly available information or from paid subscription services. But FDA’s transparency makes that information more readily available, and hopefully more reliable, than before. The updated list is also indicative of FDA’s commitment to better communication with the industry as a whole.

FDA continues to make good on its promise to improve efficiencies in the ANDA approval process and to reduce distortions of the balance between innovation and access to medication underlying the Hatch-Waxman regulatory scheme.

For More Information

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