FDA Issues Draft Guidance On Citizen's Petitions

On January 21, 2009, the Food and Drug Administration

("FDA") issued a draft guidance titled "Citizen

Petitions and Petitions for Stay of Action Subject to Section

505(q) of the Federal Food, Drug, and Cosmetic Act," setting

forth the FDA's interpretation of the new provision for public

comment.

Section 505(q) applies to citizen petitions submitted pursuant

to 21 C.F.R. § 10.30 and to petitions for stay of FDA action

submitted pursuant to 21 C.F.R. § 10.35 (collectively referred

to as "petition(s)"). When these petitions request that

the FDA take action relating to a pending 505(b)(2) application or

abbreviated new drug application ("ANDA"), Section 505(q)

provides that approval of the 505(b)(2) application or ANDA will

not be delayed, unless the Secretary determines that a delay is

necessary to protect the public health. Additionally, under Section

505(q), the FDA must "take final agency action on a petition

not later than 180 days after the date on which the petition is

submitted."

The FDA's draft guidance discusses how the FDA will

determine if Section 505(q) applies to a specific petition. First,

the FDA addresses several procedural requirements.

The FDA interprets Section 505(q) to apply to petitions that

were submitted on or after September 27, 2007.

The FDA states that the petition must be submitted in writing

and pursuant to 21 C.F.R §10.30 or §10.35 and "may

not cross-reference or rely upon information that is not included

in the petition."

The FDA states that there must be a pending 505(b)(2)

application or ANDA at the time the petition is submitted.

The FDA interprets Section 505(q) to apply only to petitions

that request the FDA to take action that may delay the FDA's

approval of a pending 505(b)(2) application or ANDA.

Additionally, Section 505(q)(4) itself provides two exceptions:

it does not apply to petitions "relat[ing] solely to the

timing of approval of an application pursuant to ... section

(j)(5)(B)(iv)" (the 180-day exclusivity provision) or

petitions from the sponsor of the application that "seek only

to have [the Secretary] take or refrain from taking any [form of]

action with respect to that application."

The FDA then addresses how it will determine whether a petition

will delay approval of a 505(b)(2) application or an ANDA. Should a

particular petition satisfy all of the procedural requirements

outlined above, the FDA will then determine if the petition may be

denied pursuant to section 505(q)(1)(E), "which allows...