AstraZeneca Backs FDA Review

WASHINGTON Pharmaceutical company AstraZeneca told the Food and Drug Administration today that it would support legislation requiring drug manufacturers to submit all prescription drug ads to the regulatory agency for review prior to public dissemination. Under current FDA rules, submitting ads in advance is voluntary.

AstraZeneca made its comments to the FDA in written testimony during a two-day public hearing that the regulatory administration is holding on direct-to-consumer advertising of prescription drugs.

Drug companies spent more than $4 billion on DTC ads last year, per Nielsen Monitor-Plus.

“If our collective goal is to ensure that accurate and responsible information is communicated to patients and healthcare providers, then manufacturers, patients, physicians and policy makers ought to welcome such a review process,” said AstraZeneca’s senior vice president of commercial operations Tony Zook, in a statement.

This is the pharmaceutical industry’s latest move as it seeks to ward off the threat of government regulation. The drug industry’s trade group, the Pharmaceutical Research and Manufacturers of America, adopted a set of guiding principles for DTC ads in July following a decision by Bristol-Myers Squibb to cease advertising drugs directly to consumers during their first year on the market.

The FDA is holding the hearing to determine the steps it can take to improve the quality of DTC ads. While no one expects the FDA to eliminate DTC ads entirely, the federal agency could issue new rules that could change some of the current requirements. Making sure prescription drug ads adequately list the risks as well as the benefits of a new drug is among one of the FDA’s main concerns.

J. Patrick Kelly, president of U.S. pharmaceuticals at Pfizer, told the FDA that DTC ads do a good job of encouraging patients to talk to their doctors about health conditions, but they could do more to help patients understand the potential risks and the benefits. “Let’s continue to expand information options and not limit them,” Kelly said.

But critics of DTC ads, such as health insurance companies, told the FDA that DTC ads lead to doctors prescribing more expensive drugs. A Kaiser Permanente study found that DTC ads promote the overuse of newer drugs.