Lawyer builds a case for greater FDA oversight

William B. Schultz, 59, partner at the Washington offices of Zuckerman Spaeder LLP, focuses on laws related to food, drugs, and the public interest. Those interests merged when he opposed a lawsuit filed by a patient advocacy group, the Abigail Alliance, which sought greater access to experimental drugs. Schultz, working on behalf of a different group of patient advocates, endorsed the robust clinical trials that the Food and Drug Administration now requires before allowing patients wider access to promising therapies. On Aug. 7, the US Court of Appeals for the District of Columbia Circuit ruled against the lawsuit; a US Supreme Court appeal is likely. As deputy assistant attorney general, Schultz also supervised the Department of Justice's lawsuit and appeals against the tobacco industry. Schultz spoke with Globe reporter Diedtra Henderson.

Q: The Abigail Alliance lawsuit, which seeks earlier access to experimental treatments, appears to cut to the core of the FDA's mission. Is that a reasonable take?

A: In Abigail Alliance, some patients were arguing that the terminally ill had a constitutional right to purchase drugs from companies after only the most minimal testing for safety - and before any testing to find out whether they worked. The concern was that if drug companies could market drugs without testing them, they'd have little incentive to do the rigorous and very expensive testing that the FDA requires.

The FDA's major contribution to medical care is its review of drugs for safety and efficacy before they can be marketed. Without that testing system, medical care as we know it would be very, very different.

Q: Better or worse?

A: In my opinion, it would be significantly inferior.

Q: On another regulatory topic, you've had a hand in tobacco issues for years. What good could come from FDA oversight of tobacco?

A: Tobacco is the number one preventable public health problem in this country. The number of people who die from using tobacco is greater than the number who die from most of the other things that we worry about: It's greater than the number of people who die from adverse reactions to drugs, from alcohol, from fires, from environmental contaminants. It's greater than all of those put together.

So, if we can make a dent in tobacco use, we have the opportunity to make great strides for the public health. If Congress gives the FDA the jurisdiction to regulate tobacco, it means the agency will have an opportunity to adopt rules that will reduce tobacco use among children.

Also, what are coming in the next number of years are the so-called reduced-risk tobacco products. Unless the FDA or some agency is given the authority to review those claims and decide whether the science supports them, then we're really at risk of going backward.

Q: Do you foresee any downside?

A: I don't, if the FDA does the job that it's expected to do in implementing the statute. The way the statute is written, its regulation of tobacco would take into account all aspects of public health. It would take into account the effect of the regulations on current smokers, the effect on future smokers. And its basic mission would be to take actions that promote public health, in the largest sense.

Q: Each new FDA duty often comes with a fee, in this case a tobacco tax that would generate more money than industry fees paid to speed drug reviews. Any questions or concerns?

A: This has qualified as a user fee, not a tax. The user fee, which will fully fund the program, is critical.

Q: Congressional staffers worked through kinks in a sweeping FDA reform bill during the August recess. Some speculate that legislation will not become law by September, which the FDA needs to avert layoffs. True?

A: I think it is likely that the issues will be resolved by the end of September and that the bill will be passed, but I don't think [September] is critical. In 1997, the [Prescription Drug User Fee Act] wasn't signed into law until some time in November. There were no layoffs. The FDA functioned. If [Congress] needs more time, it will take it. I don't think there will be dire consequences.

Q: With ongoing tension over the nuts and bolts of that bill, what's the likelihood of adding a provision to allow the FDA to approve generic versions of biologic drugs?

A: It's possible, but it's an uphill battle.