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by Cynthia Robbins-Roth, Ph.D.

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Biotechnology Soap Opera: FDA, Sex, Politics, Religion

By Cynthia Robbins-Roth
BioWorld Today Columnist

On May 18, the FDA Vaccine Advisory Committee voted 10-to-0 in favor of Merck's Gardasil vaccine for preventing cervical cancer and genital warts. A final decision by the FDA is expected by June 8.

Given the rarity of the FDA ignoring a unanimous vote of confidence by its advisory panels, and the clear medical benefit of sending papillomavirus diseases to extinction, why are women's health care advocates watching the FDA like hawks?

Because in 2005, Barr Lab's Plan B, a prescription contraceptive recommended by an FDA advisory panel 23-4 and supported by FDA staff as over-the-counter ready, was blocked by former FDA commissioner Lester Crawford, due to former FDA commissioner Mark McClellan meeting in 2003 with a senior White House official to discuss the application.

Those two cases involve social issues beyond the straightforward medical safety and efficacy data supporting the products.

Both are under attack by political forces wanting to control access not because they cause nasty health problems or are not effective, but because they operate in women's health care issues related to sexual behavior and reproduction.

It's not abortion politics, it's actually a fight to insert a new mission into the FDA's charter - approving new products only if the social ramifications fit the “acceptable” category. The question is: Who gets to decide what social effects are acceptable?

Your product might be next.

Plan B Hits Black Hole

This story has the makings of a great soap opera: sex, politics, religion and scandal. For readers who have not followed the story, the full timetable can be found at, but the short version is that OTC Plan B and Bush's nomination for FDA commissioner are trapped in limbo.

What's new here is the lobbying might ($30 million-plus since 2000) and marketing power of Merck. Its Gardasil vaccine shares common ground with Plan B: Some people desire to prevent adolescents - based on sexual concerns, not medical or scientific data - from using the product.

Susan Wood resigned her post as director of the Office of Women's Health at the FDA on Aug. 21 as a protest when Crawford deferred a decision yet again.

While Crawford resigned one month later, she said the Plan B mess is a political attack on women's health care and contraception.

Wood also is concerned about the FDA's ability to carry out its core mission - approving drugs that it considers safe and effective.

“Plan B is not a controversial product,” Wood said. “It is simply contraception, high-dose birth control pills that prevent unintended pregnancy when used within 72 hours. The panel agreed on the safety and efficacy of the product.” The OTC move would make it more likely that women could access the product within the 72-hour time frame.

“This is not something that should have gotten a lot of attention. And yet we watched the science and normal process at FDA overturned. We now know a small group of people with inordinate influence are able to subvert the process. This tells us it can happen again,” Wood said.

That is dangerous for the FDA and its credibility.

“The agency has been the international gold standard for regulatory process,” Wood said, adding that the blocking was “a complete disregard of staff and its expertise. It will have a long-term impact on the agency beyond this one product.”

The same people who objected to Plan B also have issues with Gardasil, Wood said, because they think it would promote risky sexual behavior.

“To say you object to a cancer vaccine is more easily countered,” she said. “They don't object to it being approved, but don't want it imposed as a required vaccine - rather, parents should make that decision.”

Wood sees the battle moving to the state level, where it would try to block the anticipated CDC and FDA recommendations to use the vaccine in hopes of knocking the virus out of the population.

FDA As Social Engineer?

So who are the folks driving this crucial fight over changing the way the FDA works?

The Christian Medical & Dental Association (CMDA), a 17,000-member component of a larger international organization with 54 national chapters, is participating. I spoke with Gene Rudd, their associate executive director and an OB/GYN specialist.

Rudd said that CMDA believes pre-marriage abstinence is the safest practice for sexual health, but if patients don't take that advice, “you try to find the next step that will help them stay healthy.”

How does blocking the Plan B new drug application fit into that perspective?

Rudd didn't argue with Plan B's safety or efficacy but was concerned about broader social health problems that easy access could cause.

He agreed that there was an intention to do something good - decrease unwanted pregnancies and decrease abortions - but said that OTC Plan B would give women, especially young women, poorer health care by allowing them to circumvent physicians who would give the best care, treatment and better contraception options. Thus, the FDA should block it.

When asked if the FDA should consider social issues when reviewing new drug applications, Rudd said, “I sure hope so. It's not just if a product is safe or not. We don't want FDA to ignore social health and behavior concerns in the drug approval process. We don't want to approve a product that works, but creates deleterious effects on the whole population.”

Barr Lab's Perspective

Next stop: Carol Cox, of Barr Labs, who gave her company's take.

“Barr has annual revenues of more than $1 billion, with $30 million from the prescription Plan B. We sell 22 oral contraceptive products through a 250-person women's health care team. We found doctors very appreciative that Barr tried to take it OTC [in April 2003] and has continued to put a lot of support behind the product,” she said.

She added that Barr knew “there were differing opinions out there,” but the advisory panel “confirmed that Plan B met all the criteria for OTC approval.”

Cox said Barr has been careful to not “guide investors about the potential OTC market value. It's always key for public companies not to overpromise on things over which you have no control.” Like the FDA.

Making FDA Politics-Free

So how to maintain FDA independence from political and social lobbying?

Wood pointed out that Congress is responsible for providing FDA oversight, funding and legal authority. Henry Waxman, Hillary Clinton and Patty Murray have been leading the charge by demanding an explanation for the FDA's behavior and blocking Bush's commissioner nomination.

Wood said BIO and industry need to insist that Congress ensures a strong and independent FDA, or we risk much more than two products.

Her concern is supported by the May 24 The Wall Street Journal Online/ Harris poll that showed 70 percent of people asked felt that the FDA does a bad job keeping innovation coming into the marketplace, and 80 percent are concerned that it does not make decisions independent from outside influences.

More than 60 percent said the FDA does a bad job deciding which drugs can go OTC or generic.

Here are the questions I struggle with: Is it wrong to consider the broader impact of FDA decisions on our society? And if it's right, who gets to make that decision, and how? Do I really want government - which is doing such a bang-up job of making great decisions in every other sector affecting my life - affecting decisions that should be made by myself and my doctor? Do I want companies that stand to make revenue driving the process?

Make your voice heard now, before the FDA is trapped in that black hole with Plan B.

-- June 5, 2006

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by Cynthia Robbins-Roth, Ph.D.

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