Citizen petitions are not the proper forum to prompt FDA to enforcement activity, the agency says.

FDA needed eight years but few words to deny Paddock Laboratories' citizen petition requesting enforcement action against manufacturers of OTC ammonium lactate 12 percent cream and lotion. FDA posted Paddock's petition and the agency's July 19 response online Aug. 9.

"You request that we take enforcement action against the companies that you assert are marketing unapproved and misbranded new drug products," Center for Drug Evaluation and Research Director Janet Woodcock wrote. "This request is not an appropriate request for a citizen petition."

Minneapolis-based Paddock in September 2002 requested that FDA advise Upsher-Smith, Clay-Park Laboratories and SDR Pharmaceuticals their ammonium lactate 12 percent lotion and cream products are unapproved and misbranded and demand the products' recall. If the companies failed to recall their products, Paddock asked that FDA take enforcement action, such as seizure or injunction.

Woodcock said the agency generally decides on a case-by-case basis whether to initiate enforcement actions and requests for the agency to do so "are not within the scope of FDA's citizen petition procedures." However, the CDER director did not say what procedure would be appropriate. It is unclear whether the agency plans to take any enforcement action independent of the request.

Upsher-Smith's ammonium lactate product AmLactin , SDR's Lactrex and Clay-Park's generic product are OTC; Paddock's Lac-Hydrin is Rx.

FDA Asks For Help, Not Directions

The agency often says it relies on firms for alerts about a competitor's potentially violative behavior, especially in the realm of advertising and promotion. But the Paddock example illustrates alerting FDA to a concern does not mean the agency will agree and take action.

FDA's response to Paddock follows its denial of a 2008 citizen petition asking the agency to seize foods with stevia-derived ingredients. In its reply to Washington law firm Coburn & Coffman, FDA noted citizen petitions cannot request enforcement action (¹ 'The Tan Sheet' Dec. 14, 2009, In Brief).

Paddock's petition and FDA's denial also show the challenges the agency faces as it implements the Unapproved Drugs Initiative; sponsors that have put the time and money into getting approval want products that have not made the same effort removed from the market, even if the agency worries about the potential reduction in supply (² Also see "FDA Adds $24.2 Million To Unapproved Drug Initiative Scorecard" - Pink Sheet, 4 August, 2008.).

FDA's 2007 crackdown on firms marketing unapproved timed-release guaifenesin combination products generated a rapid increase in sales of the Mucinex line owned by Adams Respiratory Therapeutics, now part of Reckitt Benckiser. The agency initiated the enforcement in 2002 when it approved Adams' application for single-ingredient guaifenesin 600 mg extended-release product for OTC use (³ Also see "Reckitt Benckiser Looks Overseas To Double Adams’ Revenue" - Pink Sheet, 17 December, 2007.).

OTC Products Lack Approvals

Paddock claimed the competing topical products, used to treat dry and itchy skin, lacked an approved new drug application or abbreviated NDA.

The petition stated the "products are recognized as substitutes for FDA-approved, prescription ammonium lactate 12 percent lotion and cream."

Paddock noted FDA had approved four drug applications for ammonium lactate 12 percent, including Paddock's ANDA. The company said Clay-Park also obtained an ANDA approval for an ammonium lactate cream yet was marketing a lotion product without comparable regulatory approval.

In addition, Paddock claimed the labeling for these products did not include adequate directions for use, did not bear required label statements such as "Rx only," and had misleading comparative claims.

"Upsher-Smith's, Clay-Park's, and SDR's unlawful distribution of their products, and misrepresentations as to safety and effectiveness, also raise important questions of fundamental fairness and threaten real economic harm to competitor companies that are playing by the rules," the petition stated.

"Paddock Laboratories, for example, has expended significant time and resources to conduct clinical studies and other activities to support FDA approval of its 12 percent ammonium lactate lotion."

- Brenda Sandburg ( ⁴ b.sandburg@elsevier.com )

Citizen Petitions Are No Place To Request Enforcement Action - FDA

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