By Kim Coghill

Washington Editor

WASHINGTON ¿ A House subcommittee in the next two weeks will hear testimony on the effectiveness of the Prescription Drug User Fee Act (PDUFA), scheduled to expire at the end of fiscal year 2002.

PDUFA, which authorizes FDA to collect fees from companies that produce human drug and biological products, was extended by Congress as part of the FDA Modernization Act (FDAMA) of 1997.

Brent Del Monte, majority counsel for the House Energy and Commerce Committee, addressed a Food and Drug Law Institute conference in Washington Wednesday, saying the Health Subcommittee is expected to hold a hearing May 3 to collect updated information on the success of FDAMA and PDUFA.

¿We want to educate our members on what is working and what is not working,¿ Del Monte said. ¿We hear different numbers from different people ¿ some tell us the FDA is doing great, and is that true? I don¿t know, the members don¿t know, that¿s why we want the FDA there and we want industry there so we can find out what is going on and set the stage for reauthorization.¿

PDUFA provides FDA with additional revenue earmarked toward hiring more reviewers and support staff and upgrading its information technology to speed up the application review process for pharmaceutical and biological products without compromising review quality. By law, PDUFA fees can be used only for specific costs related to the review of human drug and biological products, as defined in the PDUFA. No PDUFA user fees are assessed for genetic drugs, most over-the-counter drugs, blood products, foods, cosmetics, medical devices or animal drugs.

Last year, Tufts Center for the Study of Drug Development released a study saying that since 1992 the total drug development time in the U.S. has dropped by 18 percent.

In her address to the conference, Linda Suydam, the FDA¿s senior associate commissioner, said PDUFA is considered a success by the FDA and industry leaders. Since PDUFA¿s implementation, Suydam said the average drug approval time has dropped to 12 months and for priority drugs it has dropped to six months. ¿This means about $4 billion to drug companies and the faster review times reduce the overall costs to the drug companies. The harder we work under PDUFA, the more drugs enter the market and get to the public.¿

Hatch-Waxman Generates Buzz On Hill

The Hatch-Waxman Act of 1984, considered outdated by some on Capitol Hill, also is the subject of ongoing behind-the-scenes debate.

¿There seems to be a lot of talk about reforming Hatch-Waxman,¿ Del Monte said. ¿But I caution, it is going to be difficult to move anything if there¿s not a broad consensus. We would urge anyone involved with Hatch-Waxman to sit down with us.¿

Del Monte said the general opinion is that Hatch-Waxman, which created the generic drug industry, ¿has worked pretty darn well for the last 20 years. We went from having less than 20 percent of prescriptions being filled by generics to 50 percent ¿ and that¿s great. At the same time, brand name profits have been rising and those companies are funneling money back into research and we wanted that to happen.¿

John Ford, counsel for the House Energy and Commerce Committee, told conference attendees that Hatch-Waxman was not enacted to reduce prices without ¿minding the business of the innovator.¿

¿When that law was enacted, we didn¿t have much of a biologics industry out there,¿ Ford said. ¿I can¿t imagine today that we would write law and ignore the biologics industry.¿

Hatch-Waxman last year began receiving press when Columbia University requested an 18-month extension on its patent for cotransformation of mammalian cells ¿ the process allowing foreign genes to be inserted into mammalian cells to produce proteins. The university did not get the extension.

Under Hatch-Waxman, companies producing drugs can receive patent extensions for up to five years to compensate for regulatory delays caused by the FDA. Columbia argued that those same delays lessened the value of the cotransformation patent by preventing Columbia from collecting royalties on sales of products utilizing the technology. (See BioWorld Today, May 19, 2000.)

Reimportation Issue Likely To Resurface

In a climate that includes lots of discussions about prescription drugs, is seems unlikely that the issue of reimporting FDA-approved prescription drugs from other countries will be swept under the rug for good.

¿If reimportation comes up again, we want to make sure we get the experts back in and that it follows regular committee orders,¿ Del Monte said. ¿Reimportation has fallen into Secretary [Tommy] Thompson¿s lap and I hear he is reviewing it.¿

As part of an annual agriculture appropriations bill, former President Bill Clinton approved the drug reimportation amendment last November. In December, however, former secretary of Health and Human Services Donna Shalala declined to implement reimportation, citing loopholes in the plan and cost and safety issues. (See BioWorld Today, Dec. 29, 2000.)

Earlier this year, Sen. Jim Jeffords (R-Vt.) commissioned a legal analysis by the American Law Division of the Congressional Research Service, which determined the Bush administration has the power to overturn Shalala¿s decision.

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