AEGiS-WSJ: FDA Chief Targets Europe's Controls On Drug Prices

Important note: Information in this article was accurate in 2003. The state of the art may have changed since the publication date.

FDA Chief Targets Europe's Controls On Drug Prices

Wall Street Journal - September 25, 2003
Anna Wilde Mathews, Staff Reporter of The Wall Street Journal

WASHINGTON -- The head of the Food and Drug Administration is expected to warn that wealthy nations need to more fairly share the cost of developing new drugs, and to criticize price controls maintained by some European and other countries that force Americans to shoulder too much of the burden.

The message from FDA Commissioner Mark McClellan comes as the disparity between U.S. and foreign drug prices is becoming an increasingly potent political issue, and Americans are seeking to import cheaper medicines from Canada and abroad.

The FDA has opposed bills before Congress that would ease restrictions on the practice, arguing that the agency can't assure the safety of drugs coming from beyond U.S. borders.

In a draft of a speech Dr. McClellan is expected to deliver Thursday to a group of international pharmaceuticals executives meeting in Cancun, Mexico, the commissioner says "we are not all paying our fair share of the costs" of bringing new medicines to the world. The U.S. "cannot carry the lion's share of this burden for much longer," he says later.

If it becomes a higher-profile priority for the Bush administration, the issue could open up a new point of tension between the U.S. and European nations already at odds over Iraq and other matters.

But it isn't clear what, if anything, the U.S. could do to raise drug-price controls as a trade concern. The speech reflects discussions within the administration, according to a person familiar with the matter.

Americans account for about half of world-wide pharmaceuticals spending, Dr. McClellan's draft says. He is expected to warn that "everyone's effort to get a free ride on new drugs will grind the global development of new drugs to a halt." That would be "unfair and unjust," he says, adding, "it's unfair to Americans, who are bearing an increasing share of the burden, and cannot be expected to do so indefinitely," and also to the rest of the world.

The World Trade Organization recently agreed that poor countries can import generic copies of patented drugs for health scourges such as AIDS, and drug-making nations such as Brazil can produce such drugs if they export the copies at low prices solely to needy nations. That may also put more pressure on wealthy nations to support drug development.

In the draft speech, Dr. McClellan proposes that industrialized nations work together to find ways to fairly divide the cost. One option, he says, might be to tie drug expenditures to a nation's ability to pay. The "average price of important medical breakthroughs ought to bear some relation to a nation's income," the draft says.

Dr. McClellan, an economist and physician who served as a White House official before taking over as FDA commissioner in November, has made drug-price concerns a high priority. He has encouraged initiatives, such as a move to speed the approval of generic drugs in the U.S., that are designed to curb escalating prescription-drug costs. He has also said he wants to make the FDA's drug-review process quicker and more efficient.

Write to Anna Wilde Mathews at anna.mathews@wsj.com
030925
WJ030909

AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Boehringer Ingelheim, Bridgestone/Firestone Charitable Trust, Elton John AIDS Foundation UK, the National Library of Medicine, AIDS Walk of Orange County, and donations from users like you.

Always watch for outdated information. This article first appeared in 2003. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2003. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .