FDA should "clarify" that Waxman/Hatch reforms included in the Medicare law still allow for more than one 30-month stay on ANDA approval in some cases, the Pharmaceutical Research & Manufacturers of America said in comments submitted to FDA's generic drugs docket.

"FDA should issue a guidance document or regulations clarifying that the new...provisions do not limit manufacturers to one 30-month stay per challenger but instead provide that 30-month stays apply only to those patents submitted to FDA prior to the submission of the ANDA or 505(b)(2) application," ¹ PhRMA's comments to the agency state.

PhRMA conceded the "practical effect of this provision likely will be to preclude non-concurrent, 30-month stays for most drug products."

Nevertheless, multiple stays "still are possible in situations were the ANDA and 505(b)(2) applicant changes its patent certification," PhRMA asserted.

PhRMA submitted the May 3 comments in response to FDA's request for input on additional regulations that may be needed as a result of the Medicare law's generic drug reform provisions (² Also see "FDA Wants Comments On Generics Law, But Not Declaratory Judgments" - Pink Sheet, 8 March, 2004., p. 6.).

The trade association provided a scenario under which more than one 30-month stay could occur.

"If an ANDA applicant submits two patent certifications in its original application - a Paragraph III certification to one patent and a Paragraph IV certification to another - then changes its Paragraph III to a Paragraph IV six months later, the ANDA applicant would be subject to two non-concurrent 30-month stays," the association said.

"PhRMA believes that there is widespread confusion regarding this issue that FDA guidance would help dispel," the comments state.

The Medicare conference report describes the "single 30-month stay provision" as a "centerpiece" of the Waxman/Hatch reform provisions in the bill (³ Also see "Generic Rx Reforms: No Automatic “Controversy” For Declaratory Judgments" - Pink Sheet, 24 November, 2003., p. 10).

PhRMA's request that FDA clarify the availability of multiple 30-month stays is likely to renew criticism from the generic drug industry that innovators are trying to "game" the new system.

The Generic Pharmaceutical Association is asking FDA to take steps toward "ensuring a single 30-month stay" by making certain that accurate patent information is listed in a timely way.

A 30-month stay is only available on patents "submitted" to FDA prior to an ANDA filing, GPhA notes in May 5 comments.

"Because the statute uses the phrase 'submitted' to the agency, rather than 'published' by the agency, multiple stays are possible if the agency does not timely list all of the patent information submitted by the NDA holder," ⁴ GPhA's comments state.

"In order to ensure that ANDA applicants are subject to only one stay, as Congress expressly intended, NDA holders [should] be required to confirm the accuracy of the patent listing information in the Orange Book."

"The NDA holder [should] be required to review the listed patent information and report any errors or omissions to the agency within 10 days," GPhA suggested.

"The agency would promptly make the necessary changes, ensuring that ANDA applicants have up to date information when preparing and submitting their applications."

Under the Medicare law, an ANDA filer that has been sued for infringement may bring a counterclaim to correct or delete listed patent information on the grounds that the patent does not claim either the drug for which the NDA was approved or an approved method of use.

GPhA also suggested FDA retain a flexible approach in allowing ANDA filers to "bundle" different variations of a drug product into a single application (see ⁵ [A#00660200021] ).

[Editor's Note: A version of this story first appeared in ⁶ "The Pink Sheet" DAILY May 12. Visit our website, www.ThePinkSheetDAILY.com, to sign up for a free trial.]

Waxman/Hatch Reforms Still Allow Multiple 30-Month Stays, PhRMA Says

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