Dave and all, more info on FDA review hearings in this Bloomberg article:
Pfizer's Viagra Needs FDA Panel Review, Public Citizen Says
Bloomberg News
August 20, 1998, 3:24 p.m. ET
Pfizer's Viagra Needs FDA Panel Review, Public Citizen Says
Washington, Aug. 20 (Bloomberg) -- Pfizer Inc.'s Viagra
impotence drug should be reviewed by a U.S. Food and Drug
Administration advisory panel because of safety concerns, a
Washington-based watchdog group said.
Public Citizen sent a letter to the FDA demanding that an
advisory committee review the impotence drug, which saw
unprecedented sales of more than $400 million in its first three
months on the market. While the FDA often asks expert advisory
panels for their opinions on new drugs, the agency didn't hold a
meeting before approving Viagra.
The committee ''was completely bypassed during the
dangerously-rushed six months between the submission of the new
drug application for Viagra to the FDA and its approval,'' Public
Citizen said.
The FDA and Pfizer have repeatedly said that the drug is
safe when it is used correctly. While the FDA has confirmed that
39 men who took Viagra later died, the reports haven't caused the
agency to change its stance that the drug is safe and effective.
Many of these men were taking heart drugs that are known to have
dangerous interactions with Viagra and are highlighted on the
drug's label.
An FDA spokesman said the agency had just received the
letter and was still reviewing it. Officials from New York-based
Pfizer weren't immediately available for comment today.
Unusual Procedure
While unusual, such a hearing -- after a drug's approval --
wouldn't be unprecedented. The agency held such a hearing several
years after the approval of Eli Lilly & Co.'s wildly successful
depression drug Prozac, for instance, on concerns about how it
affected behavior.
''The FDA has in the past held these hearings,'' said Ira
Loss, an analyst with HSBC Washington Analysis. They create a
''public record'' that the FDA and company can use to defend the
drug, he said.
Viagra and Prozac are similar in that they've become part of
the vernacular. Since its FDA approval in March, Viagra has
become ''the subject of discussions at every cocktail party,''
Loss noted. That could well spur extra attention at the FDA, he
said.
Public Citizen also expressed concern that patients who had
certain risk factors -- such as people with congestive heart
failure, a history of heart attack or poor blood flow to the
heart -- were deliberately not included in the Viagra trials for
safety reasons. The drug was approved, however, without labeling
to warn these same groups of people they may be at higher risk
and should be cautious when using the drug, the group said.
While the label doesn't contain a specific warning for heart
patients, it does advise doctors that sexual activity carries
risks and ''physicians may wish to consider the cardiovascular
status of their patients'' before prescribing the drug.
Today's letter amplifies and adds to a July letter demanding
additional safety warnings on the Viagra label, Public Citizen
said. In addition to warnings about the heart risk the drug may
hold for some patients, the group called for stronger language on
the label outlining the danger the drug may pose if taken by a
pregnant woman.
Already, women are using the drug on their own and Pfizer
has begun testing Viagra to see if it improves women's sexual
functioning.
Tests in animals, however, suggested the drug has the
potential to damage the heart, lungs or skull of an unborn rat or
rabbit fetus -- not a conclusive sign that the drug would harm
human fetuses but one which should warrant wording on the label
which reflects that the real risk is not yet known, Public
Citizen said.
Other animal findings, pointing to a possibility that the
drug could trigger inflammation of the blood vessels, were never
investigated further, the consumer protection group said.
The group also said Pfizer and the FDA have played down the
drug's potential to damage vision, cause lasting and painful
erections, and even trigger genetic alterations in the
chromosomes of the men who take the drug.
EU Panel to Meet
The group's petition came on the same day that a European
Union drug regulator said Viagra will next week face scrutiny by
a committee of European Union drug regulators, who'll recommend
whether the European Commission should formally approve its sale.
Philippe Edouard Brunet, an official in the European
Commission's pharmaceutical-products screening division, said the
committee will meet ''to discuss two or three questions they
still have'' about Viagra.
Viagra got the backing of the European Medicines Evaluation
Agency, an expert panel that advises European regulators on drug
approvals, on May 29. Final approval from the commission, the
EU's executive agency, usually comes two to three months after
EMEA approval, Brunet said. He wouldn't confirm a Belgian press
report that the drug will be approved by the end of next week.
Viagra became one of the best-selling U.S. drugs within
weeks of its April introduction, and black-market sales have been
reported around the world. EU residents have been traveling to
buy Viagra in non-EU countries such as Andorra and Switzerland.
Pfizer, the second-largest U.S. drugmaker, said it could
introduce Viagra in 50 countries by the end of the year if it
wins EU approval.
--Kristin Jensen and Kristin Reed in the Washington newsroom
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