FDA's initiative to remove unapproved new drugs from the market extends to topical ibuprofen products as the agency warns eight firms about lotions containing the common nonprescription ingredient.

The agency said Aug. 20 it issued warning letters because the firms did not submit their products through a new drug application process. With ibuprofen not included on any OTC monograph, firms need NDA approval before marketing products with the ingredient.

"There are no approved applications for topical ibuprofen products," says FDA, which launched its ongoing unapproved new drug initiative in June 2006 (¹ Also see "FDA Employs Carrot, Stick Under Unapproved Drug Enforcement Strategy" - Pink Sheet, 12 June, 2006.).

The Center for Drug Evaluation and Research says in a release that considering adding ibuprofen to an OTC monograph is on FDA's agenda, but the agency "has never proposed that topical ibuprofen be added to any OTC monograph."

FDA says topical ibuprofen "is often promoted as a 'safer' alternative" to oral ibuprofen because of the cardiovascular and gastrointestinal side effects associated with prolonged oral use.

However, the agency has not reviewed safety claims for the topical form and has no information on its potential side effects, the notice says.

"These companies have an obligation to the public to demonstrate to FDA that their products are safe and effective, and they have failed to do so," says Deborah Autor, director of CDER's Office of Compliance.

Emuprofen, BioEntopic And More

FDA sent warning letters Aug. 18 to Progressive Emu for Emuprofen ; BioCentric Laboratories for BioEntopic 15% Ibuprofen Creme; Core Products International for Ibunex Topical Ibuprofen; Geromatrix Health Products for LoPain AF 15% Ibuprofen Creme; MEKT for IB-Relief ; Ridge Medical Products for Profen HP ; Meditrend Inc. for IbuPro-10 Plus ; and Wonder Laboratories for IBU-Relief 12 .

In the letters, FDA says the product claims establish the ibuprofen-containing topicals as unapproved new drugs. The claims say the products are "intended to affect the structure or function of the body" and "for use in the diagnosis, cure, mitigation, treatment or prevention of disease."

Each firm must reply in writing within 15 business days after receiving the warning letter with a step-by-step plan on "how they will correct these violations and prevent similar violations in the future."

FDA adds that if firms cannot complete corrective action within 15 days, they must explain the delay and when they will complete the corrections.

In the warning letters, the agency informs the firms that "failure to promptly correct" the violations could prompt enforcement actions "without further notice, including, without limitation, seizure and injunction."

Further, the warning letters could impede the firms' revenue growth because federal agencies may consider the warnings "when considering the awarding of contracts," FDA says.

Progressive Emu has drafted its response to FDA, Chris Brinkley, a manager at the Birmingham, Ala.-based company, said in an interview. The firm will work with FDA to determine how to market the product legally. "If necessary, we'll remove ibuprofen from the product," Brinkley said.

Progressive Emu changed how it markets its "soothing cream" prior to receiving the warning letter, he added. "Hopefully, we've made enough changes."

FDA Commissioner Margaret Hamburg recently noted a six-step strategy for beefing up enforcement. The steps include more follow-through after issuing warning letters and allowing less time for firms' responses before taking additional enforcement actions (² Also see "FDA Enforcement Follow-Through Could Thin Out Violators" - Pink Sheet, 10 August, 2009.).

FDA's actions in the initiative on unapproved new drugs include enforcement against timed-release guaifenesin-containing drug products (³ [A#05150220003]).

Further, the agency acted against firms making unapproved new drugs that also violate good manufacturing practices or adverse event reporting requirements. In 2008, FDA seized - after the firm failed to comply and stop manufacturing - $24.2 million in unapproved drugs from St. Louis-based KV Pharmaceuticals for marketing unapproved guaifenesin-containing drugs (⁴ Also see "FDA Adds $24.2 Million To Unapproved Drug Initiative Scorecard" - Pink Sheet, 4 August, 2008.).

- Katie Stevenson ( ⁵ k.stevenson@elsevier.com )

Ibuprofen Topicals Draw Unapproved New Drug Warnings

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