By Kim Coghill

Washington Editor

WASHINGTON ¿ Congress barely had a chance to settle in from the summer recess before terrorist attacks in Washington and New York caused the temporary slowing of daily business in the House and Senate.

As things return to normal over the next few days and weeks, several issues impacting the biotechnology industry are expected to take the forefront.

It seems like months since television¿s talking heads criticized President Bush for his political appointments. Still, after eight months in office, the president hasn¿t formally announced a nominee to fill the slot of FDA commissioner.

Sometime around mid-July, at least four names floated around as possibilities and some people had expected an announcement in mid-August. The rumored candidates are Michael Astrue, senior vice president of administration and general counsel for Cambridge, Mass.-based Transkaryotic Therapeutics Inc. and chair of the Massachusetts Biotechnology Council; Eve Slater, a senior vice president of Whitehouse Station, N.J.-based Merck and Co.; Lynn Drake, a dermatologist with ties to the Republican Party; and Richard Padzur, from the FDA¿s cancer division.

Astrue reportedly was the top candidate. (See BioWorld Today, July 16, 2001.)

The Senate Health, Education, Labor and Pensions Committee will be responsible for approving the candidate, but word on the street is that Democrats, such as committee Chairman Sen. Edward Kennedy (D-Mass.), reportedly oppose any nominee who comes from the industry.

Bush also is expected to name a director of the National Institutes of Health.

Other issues facing the president and Congress have been a little more technical than simply trying to appoint the right person.

And who would have thought a year ago that Americans would get a Biology 101 lesson from the president? On Aug. 9 in a nationally televised speech, Bush enlightened the country on the basics of embryonic stem cells and agreed to pay for research on 64 existing cell lines.

The issue has refused to go away. Almost immediately following the speech, members of Congress and some scientists began to question and criticize the president¿s decision.

The Senate health committee held a hearing recently in which Kennedy and Sen. Hillary Clinton (D-N.Y.) grilled Tommy Thompson, secretary of Health and Human Services, about the viability of the 64 stem cell lines. Thompson said 24 or 25 of the approved lines are ready for research.

The National Academy of Sciences¿ National Research Council last week released a report calling for broader funding for embryonic stem cell research. The report said progress in stem cell research would be hindered without government funding.

Other Senate hearings on Bush¿s stem cells are expected.

If the stem cell research debate didn¿t create enough controversy for Congress, maybe discussions on cloning will.

The question is not whether humans should be cloned, but whether therapeutic cloning should be legal.

So far, it doesn¿t look good for the science community.

Just before the August recess, in a 265-162 vote, the House passed a bill (HR2505) authored by Rep. Dave Weldon (R-Fla.) that bans all human cloning. Bush reportedly supports the Weldon legislation. (See BioWorld Today, Aug. 6, 2001.)

The Senate will have its chance to take up the issue this fall. Either Kennedy or Sen. Dianne Feinstein (D-Calif.) is expected to introduce science-friendly legislation.

The possibility of reimporting FDA-approved prescription drugs at a cheaper price continues to bounce around Capitol Hill.

In July, the House voted 324 to 101 to approve an amendment introduced by Rep. Gil Gutknecht (R-N.M.) that prohibits FDA money from being used for policing the reimportation of drugs. The amendment is attached to the Fiscal Year 2002 Agriculture Appropriations Bill that must be approved by the Senate and signed by Bush. (See BioWorld Today, July 12, 2001.)

The original reimportation legislation was part of last year¿s Agriculture Appropriations bill and was signed in October by former President Bill Clinton. It permits reimportation of FDA-approved prescription drugs for personal use from countries with lower drug prices. And, in provisions authored by Sen. Jim Jeffords (I-Vt.), the plan permits pharmacists and wholesalers to purchase FDA-approved drugs from countries where the identical drug is sold for less. (See BioWorld Today, July 26, 2000; July 17, 2000; Oct. 2, 2000; and Dec. 29, 2000.)

The plan was never implemented because Donna Shalala, former secretary of Health and Human Services, said she could not certify that the plan was safe or that it would reduce costs.

Reimportation was supposed to be discussed last week as part of the Agriculture Appropriations spending bill, but the terrorist attacks pushed the House and Senate schedules back.

Patrick Ronan, director of health policy for the Washington-based Biotechnology Industry Organization, said Thursday that BIO is preparing for debates on agriculture appropriations this week.

Sen. Byron Dorgan (D-N.D.) said he intends to introduce an amendment allowing Americans to buy lower-priced drugs from Canada.