Washington Editor

WASHINGTON Legislators expecting tight races in November will be among the most likely to start debates on controversial issues such as prescription drugs for seniors in an attempt to shore up votes back home.

And it looks like some lawmakers might try to get a debate going by poking holes in the generic drug legislation known as the Hatch-Waxman Act of 1984.

Sen. Orrin Hatch (R-Utah), an author of the generic drug act, on Tuesday raised that issue as well as several other hot-button topics addressed at the Food and Drug Law Institute’s 45th annual education conference at the Renaissance Washington D.C. Hotel.

Hatch said there have been rumblings on Capitol Hill that Hatch-Waxman may need a few adjustments. In fact, the senator said he expects hearings to be scheduled soon.

While there’s no such thing as a perfect statute, Hatch said the renewed interest in the act centers on Congress’s inability to pass a bipartisan Medicare prescription drug program for seniors. “There are many people who are interested in this for political purposes, but I look forward to hearings on this,” he said.

He said it’s not unusual for flawed laws to be approved and enacted during election years. Hatch-Waxman saves consumers $8 billion to $10 billion annually in prescription drug costs, Hatch said.

Setting aside prescription drugs, Hatch said Congress expects a bioterrorism bill to be on President Bush’s desk by Memorial Day.

Indeed, Lester Crawford, the recently appointed deputy commissioner of the FDA, told the crowd that bioterrorism and counter-terrorism measures are the top priorities of the agency.

Currently, there are three bills floating around that deal primarily with policy surrounding bioterrorism.

Sens. Edward Kennedy (D-Mass.) and Bill Frist (R-Tenn.) introduced legislation (S 1765) calling for $3.25 billion in bioterrorism spending next year, including $1.46 billion in local and state grants. Co-sponsored by 74 senators, the Kennedy-Frist legislation is in conference. (See BioWorld Today, Dec. 17, 2001.)

Meanwhile, Sen. Joe Lieberman (D-Conn.) drafted legislation (S 1764) that would guarantee biotechnology companies pre-established prices on drugs in a predictable market, and would protect companies against liabilities from limited product trials.

Hatch said he supports certain elements of the Lieberman bill, particularly those that provide biotechnology companies with incentives to develop counter-terrorism products. Hatch said his office will work with Lieberman’s to author language that would allow countermeasure drugs to be developed based on animal data.

A third bill (HR 3448), introduced into the House by Rep. Billy Tauzin (R-La.) and Rep. John Dingell (D-Mich.), authorizes $3 billion in spending next year, including $1 billion in state and local grants that could be used to develop drugs, therapies or vaccines. The legislation passed the House in a 418-to-2 vote. (See BioWorld Today, Dec. 17, 2001.)

Even though it may be some time before any such legislation is approved and enacted, Crawford said the FDA already has received authorization to hire an additional 600 people who will work in positions resulting from Sept. 11.

“Most of these people will work in consumer safety positions out in the field, particularly at the borders to keep terrorist materials out of our country,” he said. “Historically, the FDA has not had an infusion of talent like this. If you look at this group, you will see people with degrees in chemistry and biology, and many with advanced degrees.”

On the subject of employees, Hatch said the Bush administration needs to move more quickly in its effort to name an FDA commissioner. “I am in no way suggesting that Lester wouldn’t be a superb head of this agency but this agency needs a commissioner. I am sick of the litmus tests on the nominees.

“I take exception to Sen. Kennedy saying he would oppose any candidate who comes from an agency or organization regulated by the FDA,” Hatch said. “The qualities for this position should be leadership, competence and fairness.”

Crawford was tapped in late February to serve as deputy, but some say he could end up serving as de facto commissioner. (See BioWorld Today, Feb. 28, 2002.)