Paragraph IV Gets A Date: FDA Will Announce When ANDAs Are Submitted

FDA will begin posting the date when Paragraph IV applications are filed, FDA Commissioner McClellan told the Generic Pharmaceutical Association annual meeting March 2 in Boca Raton, Fla.

The change, which is being made in response to two citizen petitions, will allow generic firms to better plan their filings and assess whether they are eligible for 180-day exclusivity on their ANDAs.

FDA had been posting information on Paragraph IV certifications, including dosage form and strengths, but will now include the date when the first substantially complete ANDA with a Paragraph IV certification was submitted.

"Previously, as you know, in response to individual inquiries, FDA provided some similar information to this," McClellan said. "But this has been a burdensome, and I believe ineffective, process for all involved."

FDA Chief Counsel Dan Troy noted that FDA would wait to post the filing date until it determined the application was substantially complete. "Ultimately, it's the date on which the thing is submitted in an acceptable form."

FDA will continue to keep the name of the applicant secret, Troy noted. The chief counsel has said trade secret laws prevent the agency from telling an ANDA applicant that it is first to file (¹ (Also see "FDA First-Generic Notification Policy May Be Reviewed" - Pink Sheet, 6 Oct, 2003.), p. 11).

"We can't give you the information to figure out who has submitted what. That said, we think...that it will help people figure out the puzzle of where you stand in the queue," Troy said.

McClellan announced the change in policy as part of a spate of initiatives designed to clarify the agency's position on ANDA procedures. Other activities include withdrawing the rule on 30-month stays, which has been superceded by the Medicare Rx law, and soliciting comments on how to implement the statute.