Drug-imports amendment could doom FDA bill to veto

The Food and Drug Administration (FDA) authorization bill on the Senate floor this week could be doomed to presidential veto if debate on an amendment that would permit medicines to be imported from abroad is not postponed.

The White House, Democratic and Republican Senate leadership and the pharmaceutical industry agree that the underlying bill should be made law, and it is expected to pass.

{mosads}But a popularly supported amendment pending to the bill could sink it if leadership fails to finalize a deal to postpone a vote on Sen. Byron Dorgan’s (D-N.D.) legislation to permit the importation of less expensive drugs from other countries. The inclusion of Dorgan’s legislation in the FDA authorization bill would lead to a veto, the White House made clear yesterday.

Democratic and Republican leadership yesterday continued to consider a unanimous consent agreement, which has evaded the lawmakers since late last week, but had yet to come to terms by press time.

Although debate on the FDA bill began Monday, leaders’ attention — and Senate floor time — has been occupied mostly by the Iraq war as Senate Majority Leader Harry Reid (D-Nev.) and House Speaker Nancy Pelosi (D-Calif.) yesterday sent a veto-bound war-spending bill to President Bush.

Dorgan indicated he would wait if the Democratic and Republican leadership were able to come to terms on a unanimous consent agreement.

“I’m willing to hold off if I get a date-certain,” Dorgan said. The bill that forms the basis of his amendment has 31 cosponsors, including five Republicans. Dorgan believes he has enough support to pass his amendment, he said.

Similar language has passed the Senate before. In 2003, the Senate voted 62–28 to attach Dorgan’s drug-importation amendment to its version of the bill that created the Medicare prescription-drug benefit. It was stripped out on conference with the House bill. In July, the Senate voted 68–32 to approve Sen. David Vitter’s (R-La.) re-importation amendment to the homeland security appropriations bill.

The pharmaceutical industry, the Bush administration and many congressional Republicans strongly oppose drug re-importation, contending the bills offer no guarantees against counterfeit or tainted drugs entering the domestic market.

“If any such importation provision were included in the final version of the bill presented to the president, the president’s senior advisors would recommend that he veto the bill,” read a Statement of Administration Policy issued yesterday by the Office of Management and Budget.

In addition to leaving the FDA bill vulnerable to a veto, the absence of an agreement complicates the task of managing the measure on the floor, which falls to Senate Health, Education, Labor and Pensions Committee Chairman Edward Kennedy (D-Mass.) and ranking member Mike Enzi (R-Wyo.).

The main purpose of the underlying bill is to reauthorize two programs through which pharmaceutical and medical-device companies pay user fees to the FDA to get new products reviewed for safety and effectiveness. These user-fee programs provide essential funds to the FDA and are supported by the drug and device industries.

The bill also includes provisions to enhance the FDA’s authority, and the manufacturers’ responsibility, to monitor the safety of drugs already on the market. Drug-makers and the White House have objected to elements of this HELP Committee-passed post-marketing surveillance language.

In addition to drug importation, Kennedy and Enzi have been fielding an array of amendments from their respective sides on issues ranging from antibiotics research to the abortion pill to advertising for prescription drugs.

Second only to the importation issue as a potential snag to the advancement of the FDA bill is legislation to grant the FDA new authorities to approve generic versions of complex biologic drugs.

The biotechnology and pharmaceutical lobbies oppose attaching legislation on “follow-on biologics” or “biosimilars” to the FDA bill. Kennedy and Enzi, along with Sens. Orrin Hatch (R-Utah) and Hillary Rodham Clinton (D-N.Y.), are working on a compromise measure but are not in agreement about whether the legislation can be completed in time to be added to the FDA bill.

Clinton and Sen. Charles Schumer (D-N.Y.) may offer their bill as an amendment this week if they do not receive a promise of floor time later this year.

The Democratic leadership hopes to wrap up debate on the FDA bill by week’s end. The Senate may vote on other matters in the meantime, however, including a pending judicial nomination. On Monday, the Senate also placed on the calendar one bill on small-business loans and another on banning discrimination for employment of health insurance based on the results of genetic testing.

Senate Majority Whip Dick Durbin (D-Ill.) insisted that the chamber would press on. “We’re going to finish the FDA bill,” he said.