By Kim Coghill

Washington Editor

WASHINGTON ¿ When Congress went back to work last January, the priorities facing the Republican-controlled chambers were much different than those that further divide the split chambers today.

But then again, the more things change, the more they remain the same.

Take for example prescription drugs for seniors. A heavily debated issue for years, prescription drugs won center stage during George Bush¿s campaign for president against former Vice President Al Gore.

A little progress ¿ but not much ¿ was made this year in developing compromise legislation aimed at lowering the cost of prescription drugs for seniors. President Bush came up with his own temporary fix, a $48 billion four-year plan called ¿Helping Hand.¿ Under the plan, states with drug subsidy programs would be eligible for block grants to help low-income Medicare patients. Opponents argue that Helping Hand would be limited in its scope because fewer than half the states have subsidy programs in place. (See BioWorld Today, Jan. 31, 2001.)

But that¿s just one plan. There were others to include prescription drug cards.

According to Capitol Hill watchers at the Washington-based Biotechnology Industry Organization, prescription drugs and Medicare issues are expected to make a splash in 2002.

From a political standpoint, Sharon Cohen, BIO¿s vice president for government affairs, said Medicare and prescription drugs will be particularly important in 2002 due to the mid-term elections. ¿I think [Congress] will be compelled to try to move forward on something,¿ Cohen told BioWorld Today. ¿In my opinion, what you will see is fairly significant dollars in the prescription drug benefit. Our hope is that they will actually enact something.¿

And since nothing ever really dies in Washington, Cohen said don¿t be surprised if another proposal to reimport FDA-approved drugs from foreign countries surfaces.

¿There are some folks on Capitol Hill who would like to come up with a way to move the drug reimportation measure for two reasons,¿ she said. ¿One, they would like to use it as a pressure point on other issues. Two, I think others who are located geographically close to other countries have constituents who may be pushing the issue ¿ they can go across the border and get prescription drugs cheaper ¿ so sometimes it is from a public relations vantage point.¿

A conference committee negotiating the $75.9 billion Agriculture Appropriations Bill for 2002 struck a House amendment that would have legalized reimportation. (See BioWorld Today, Nov. 12, 2001.)

Reimportation legislation was approved in the fall of 2000 as part of the fiscal year 2001 Agriculture Appropriations Bill and was signed by former President Bill Clinton. But Donna Shalala, Clinton¿s secretary of Health and Human services, failed to implement the legislation because she could not demonstrate that it was safe or that it would reduce costs. (See BioWorld Today, Oct. 2, 2000, and Dec. 29, 2000.)

Critics of reimportation fear the measure would prompt government price controls, or worse yet, open the borders for the sale of unapproved and unsafe drugs.

Bioterrorism Legislation Gains Steam

Other hot-button issues expected to reappear rather quickly in 2002 are bioterrorism, cloning and stem cell research.

When last checked, there were three versions of bioterrorism legislation likely to pick up some steam in the coming months.

A House bill (HR 3448), sponsored by Reps. Billy Tauzin (R-La.) and John Dingell (D-Mich.), passed in a 418-to-2 vote. Known as ¿The Public Health Security and Bioterrorism Response Act of 2001,¿ it authorizes more than $1 billion in grants to states or local governments for planning and preparedness activities, including developing drugs, therapies or vaccines to fight bioterrorism or other public health emergencies.

Just before the holiday recess, bioterrorism legislation introduced by Sens. Edward Kennedy (D-Mass.) and Bill Frist (R-Tenn.) passed by unanimous consent. The ¿Bioterrorism Preparedness Act of 2001¿ (S1765) is similar to the Tauzin-Dingell legislation.

When Congress reconvenes in January, the House and Senate versions will be forwarded to a conference committee, where negotiators will iron out differences.

Cloning, Stem Cells Prompt Lively Debate

A year ago, the concept of cloning cells, tissue or humans hardly made the evening news. Furthermore, with the exception of scientists and a few others, no one even knew what stem cell research meant. Now, thanks to advancing science and a decision made by President Bush, there¿s a peaked interest in these advanced research techniques that could result in breakthrough drugs.

Last summer, Bush announced that the federal government would pay for research on 64 (now 72) existing stem cell lines located within 10 labs across the world.

That decision set off a series of debates on Capitol Hill and on cable television stations about whether the government should spend its money on such research.

The issue sort of took a back seat to bioterrorism until late November, when Worchester, Mass.-based Advanced Cell Technology Inc. published a paper in the Journal of Regenerative Medicine saying it had created the world¿s first human embryos through therapeutic cloning, or somatic cell nuclear transfer. (See BioWorld Today, Nov. 27, 2001.)

Around that time, Sen. Sam Brownback (R-Kan.) introduced an amendment to place a moratorium on human and therapeutic cloning for six months until debates resume. The amendment was dropped at the last minute. However, the House approved legislation (HR 2505) authored by Rep. Dave Weldon (R-Fla.) that bans both therapeutic and reproductive cloning. President Bush, who opposes all forms of cloning, reportedly supports the Weldon legislation. (See BioWorld Today, Aug. 6, 2001, and Nov. 27, 2001.)

Most scientists say that banning therapeutic cloning could stifle stem cell research.

FDA Still Runs Without A Leader

The short list for the new FDA commissioner no longer includes industry favorite Michael Astrue, a senior vice president of Cambridge, Mass.-based Transkaryotic Therapeutics Inc. Astrue wouldn¿t say why he withdrew from consideration in November, but others said it was because Sen. Kennedy refused to give Astrue a hearing. Kennedy is the chairman of the Senate Health, Education and Labor Committee, which oversees the FDA.

Others who reportedly have been on the short list include Lester Crawford, a veterinarian who heads Virginia Tech¿s Center for Food and Nutrition Policy in Alexandria, Va.; Eve Slater, a senior vice president at Whitehouse Station, N.J.-based Merck and Co. Inc.; Lynn Drake, a dermatologist with ties to the Republican Party; and Richard Pazdur, of the FDA¿s cancer division.

Also over at the FDA, the Prescription Drug User Fee Act II (PDUFA II) expires in September and government workers are trying to pull a proposal together to get the act reauthorized. PDUFA authorizes the FDA to charge biotechnology and pharmaceutical companies user fees when they submit drug applications. The FDA is considering raising the cost of fees, or possibly adding extra fees. (See BioWorld Today, Nov. 26, 2001, and Dec. 10, 2001.)

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