Biotech Values

[drbio45]

Better working relationship helping industry, study says
By Craig D. Rose
UNION-TRIBUNE STAFF WRITER

http://www.signonsandiego.com/news/business/20070523-9999-1b23biotech.html

May 23, 2007

A biotechnology industry survey released yesterday found that most companies believe the Food and Drug Administration has gotten better at spelling out its expectations and approving new products.
The study – which was released by Biocom, San Diego's biotech industry group, and the consulting firm PricewaterhouseCoopers – found that 81 percent of companies said the FDA was performing better since a landmark overhaul in 1997 that levied additional fees on companies to speed up product reviews.


“This study is very important because the working relationship between the life sciences industry and the FDA has a critical bearing on the health of Americans,” said Joseph Panetta, chief executive officer of Biocom. “The good news is that these relationships have greatly improved.”
The survey, which was released one day after a popular diabetes drug was alleged to raise the risk of heart attacks, also found that most companies see the monitoring of drugs after they reach the market as a key issue.

About half the companies said the FDA and the industry should do more to monitor the effects of drugs already approved for sale, which the industry calls pharmacovigilance, on the consumers who take them.

The survey polled about 70 companies nationwide and sought a representative sample of employment levels and revenue.

The survey found that 73 percent said the FDA's improved guidance had led to a better understanding of the regulator's expectations.

But many companies said the FDA had changed positions during their drug or device reviews, which the industry says can delay the review process. And 61 percent of the companies agreed or strongly agreed that personnel changes at the FDA resulted in a break of continuity for their product reviews.

Half the companies said that target schedules for reviews had caused the FDA to reject products because the staff ran out of time to resolve issues.

The survey comes as the FDA is drawing criticism for approving drugs that turn out to be dangerous.

On Monday, the New England Journal of Medicine reported a study alleging that Avandia, an FDA-approved diabetes drug, increases the risk of cardiovascular death by 64 percent.

In recent years the painkiller Vioxx and the diabetes drug Rezulin, among other drugs, have been pulled from the market because they were implicated in causing harm to patients or death.

In response, the Senate and House have separately passed drug safety bills and are in the process of reconciling the two. The Senate bill would double the number of government scientists to monitor risky side effects from drugs already approved for sale.

Dr. Sidney Wolfe, who monitors the industry for Public Citizen, a Washington-based watchdog group, said the FDA's performance in protecting public health over the past decade has gotten “significantly worse.”

He blamed an increasing reliance on funding the FDA from the industry and a decline in congressional oversight of the regulator. More than half the FDA's drug approval budget is now coming from the industry, Wolfe said.

“The same Congress that has abdicated funding of the FDA to industry has not done a fraction of the oversight that it used to do,” said Wolfe, who is a physician. “The FDA is getting closer and closer to the industry.”

Wolfe also said turnover at the FDA had increased because scientists and doctors had left because their professional judgments are too often overruled by superiors in what he said was an agency that increasingly “kowtowed” to industry.

Panetta of Biocom also said the increased reliance on funding from industry fees was a problem. But he said FDA turnover was more likely a function of a high pressure work atmosphere and limited resources.

Panetta said public attitudes about approved drugs also need adjustment.

“Part of the breakdown in public confidence is due to the fact that there was and is a lack of understanding that all drugs carry a certain level of risk,” he said.

“Along with the benefits, there is also going to be the potential for side effects. But the survey found industry overwhelmingly said we need to increase pharmacovigilance.”



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Craig Rose: [phone]; [e-mail]