Even before Pfizer actually asks FDA to move Viagra from Rx to OTC status, the AIDS Healthcare Foundation says it will petition FDA to reject the drug maker's possible switch application for the erectile dysfunction drug.

Los Angeles-based AHF, which has filed a lawsuit alleging Pfizer's Viagra advertising campaigns violate California business law, said Feb. 14 it will seek not only to "pre-empt consideration" by FDA of a Viagra switch, but explain its contention Pfizer promotes the product as a "lifestyle drug" and not as a pharmaceutical remedy for a physical problem.

The foundation cites a warning letter FDA sent Pfizer in 2003 concerning Viagra ads. Pfizer agreed to pull the ads after FDA's letter was made public.

In the letter, FDA said, "The TV ads omit the indication for the drug and fail to provide" risk information about the drug.

Pfizer has not filed a switch application for Viagra, but the firm in January said it is considering a switch (¹ Also see "Viagra Non-Prescription Switch Would Face High Bar For Safety" - Pink Sheet, 15 January, 2007., p. 3).

Supporters of the switch say the limited number of safety concerns make Viagra an ideal OTC candidate. Meanwhile, some critics say concerns like blindness and drug interactions could be expanded by inappropriate selection and off-label use.

AHF in early 2006 criticized Pfizer's holiday-themed print ad campaign the foundation says "promoted unsafe sex by encouraging the recreational use of Viagra." Pfizer "continued this irresponsible advertising campaign" despite objections by AHF.

The group's petition to FDA "reinforces [AHF's] concern over Pfizer's questionable marketing tactics for Viagra that the Foundation believes encourages [its] recreational use ... and which the Foundation also believes ultimately contributes to increased risks for individuals' exposure to sexually transmitted diseases, including HIV, by people using ED drugs with other drugs such as crystal methamphetamine," AHF says.

AHF says sales restrictions on pseudoephedrine - to prevent meth abuse - bolster the argument for keeping Viagra prescription-only. Federal law requires all PSE-containing drugs to be sold from behind store counters (² Also see "Pseudoephedrine Will Be Behind The Counter Across The Country By October" - Pink Sheet, 6 March, 2006., p. 5).

"FDA ought to be similarly proactive and keep Pfizer's Viagra as a doctor-prescribed medication," AHF President Michael Weinstein says.

In a lawsuit filed Jan. 22 in California Superior Court in Los Angeles County, AHF alleges "unlawful, unfair and fraudulent business practices" violating state laws.

The foundation says Pfizer's marketing of "Viagra has caused an increase in the spread of sexually transmitted diseases including but not limited to HIV/AIDS."

In the lawsuit, AHF seeks injunctions prohibiting Pfizer from pursuing its "allegedly unlawful and deceptive marketing of Viagra" and requiring Pfizer to conduct campaigns to inform the public about the inappropriate nature of the ads and to educate gay men about "STD risks associated with using Viagra."

The foundation also asks for an order requiring Pfizer to forfeit revenues linked to inappropriate Viagra advertising and to repay AHF for its costs from treating people who became infected with HIV or other STDs in behavior encouraged by Pfizer's ads as well as its costs for public education campaigns on the risk of combining Viagra and meth.

AHF said in 2006 it asked Pfizer for a grant to support a program to warn about recreational use of Viagra, particularly in combination with meth. The grant was not awarded, the foundation said.

The foundation also said it would submit a letter to the U.K. Medicines and Healthcare products Regulatory Agency criticizing pharmacy chain Alliance Boots' six-month, three-store trial program to give 30- to- 65-year-old men access to Viagra without a prescription.

Boots' offer requires customers to provide pharmacists with medical histories and have blood pressure and cholesterol- and glucose-level tests. If approved, customers can buy four Viagra pills for $97, but they will need prescriptions for refills, Boots said.

"We believe offering this drug over the counter ... is reckless and a potential danger to public's health," says Whitney Engeran III, AHF's prevention director.

New York-based Pfizer did not comment on AHF's letter or lawsuit. The firm said it is not involved with Boots' Viagra offer and the results of that program will not influence whether it asks FDA to switch Viagra.

- Malcolm Spicer (m.spicer@elsevier.com)

Possibility Of Viagra Switch Stirs AIDS Healthcare Group Into Action

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