FDA Legislation Proposals

Someone should tell the drug and medical device industries that they’ve never had it so good. Bulging sales, profits and executive compensation, spiraling stock prices and the absence of a major product catastrophe swirling in the news and inside law enforcement agencies — that is having it all.

One reason for this balmy environment is that the Food and Drug Administration (FDA) and judicial liability laws have kept these companies more on their toes. The result has been prosperity for their income statements and the absence of thalidomide or dalkon shield-level calamities with their tens of thousands of victims. (Smaller tragedies continue to occur)

So what are the powerful drug and medical device lobbies doing these days? They are pressing Congress to weaken the FDA’s authority across the board (S. 830) and to straightjacket state judges and jurors who hear personal injury cases brought before them by wounded children, women and men or their next of kin.

There is always a cruel streak observable in many industries — which is behind so much of the corporate crime, fraud and abuse that the Wall Street Journal reports frequently. But backfiring masochism is a rarer trait that is bred from an excessive sense of power and domination over others. In short, these lobbies are out of control, far beyond possessing a sense of balance and proportion. Not in 91 years has there been a rollback of FDA authority, until now.

Without any data and without any documentation of need, these lobbies are nearing victory in the Congress and the supine Clinton White House to enact the following perils to the drugs and devices you may be buying or having prescribed shortly:

1. S.830 would make legal, for the first time, for companies to promote drugs and medical devices for unapproved uses, such as deadly combinations of weight-reduction drugs, which individually are FDA-ok.

2. Making lawful the wholesale compounding of multiple drugs by pharmacies (many of which are now using unlicensed technicians to prepare your drug formulas) without FDA approval or without meeting FDA’s good manufacturing practices requirements.

3. Lowers the standards required to prove drugs safe and effective, for example by only requiring one, not the current two or more clinical trials.

4. Permits medical device companies to “buy their own reviewer”, by avoiding expert FDA review, and hire private-for-profit contractors to determine the safety and efficacy of their products.

5. Repeals mandatory tracking and postmarket surveillance of implantable, life sustaining and life supporting medical devices. These requirements were enacted some years ago after the Bjork-Shiley heart valve disaster, which killed hundreds of people, yet more than half of the patients were not able to be identified in order to be warned.

6. Permits companies to make unproven “health economic claims” about drugs and medical devices to HMOs and other large volume purchasers.

7. Nullifies stronger state consumer protection laws covering over-the-counter drugs and cosmetics even in cases where there is no comparable federal law or protection.

There are more harmful provisions in the fine print, but the New York Times and the Washington Post had enough — they strongly opposed S.830. (So did fifty national organizations).

Dr. Sidney Wolfe — a longtime watchdog over the FDA — is especially concerned about the bill allowing massive promotion of off-label use of drugs for children. He says that “an FDA study found that many drugs, such as medicines for asthma, anti-depressants and steroids, were being widely used for children without their safety and efficacy having been established for those age groups.” Now, market promotion of such unapproved uses is unlawful. Under this foolhardy legislation, unapproved use drug promotion is made legal.

Some Senators, trying to camouflage the bill’s deadly import, say that the FDA takes too long to approve medical devices. That is what was said about drugs when Congress squeezed the FDA’s budget years ago. Then some bright soul suggested charging the drug companies fees for drug approval (like your motor vehicle registration fee) and suddenly the FDA was able to hire more expert reviewers and the problem was solved.

So why not have a similar medical device user fee pass Congress? Because if it did, they couldn’t cover up what they were surrendering to the industry.

It is hot mid-summer in Washington and Congress is in heat. They are about to take it out on people like you who rely on safety standards. You can stop them. Call your Representative or Senator (202-224-3121) and get more information about S.830 by phoning the Health Research Group at 202-588-1000.

Better yet, buttonhole your member of Congress during the month long August recess that brings them back to meet the people.