FDA’s Acting Chief Is Cleared of Affair Charges

WASHINGTON —  President Bush’s nominee to head the beleaguered Food and Drug Administration has been cleared of allegations that he had an affair with a subordinate and helped her win a promotion, a senior senator announced Wednesday.

After a two-month investigation, the inspector general’s office of the Department of Health and Human Services “found no merit to any of the charges” against acting FDA Commissioner Lester M. Crawford, Sen. Michael B. Enzi (R-Wyo.) said in a statement.

Enzi, who chairs the Health, Education, Labor and Pensions Committee, which has jurisdiction over the FDA, said he would move to schedule a panel vote on the nomination.

But Crawford’s fate remains unclear, because two prominent Democratic senators have pledged to block a vote by the full Senate.

Sens. Patty Murray of Washington and Hillary Rodham Clinton of New York want the FDA to issue a long-delayed decision on whether the “morning after” contraceptive pill can be sold over the counter.

In other FDA news Wednesday, the House considered a conflict-of-interest proposal, and an independent advisory group began an investigation into drug safety issues.

By a 218-210 vote, the House approved an amendment to prohibit the FDA from appointing scientists to agency advisory panels if they had financial conflicts of interest.

Such conflicts could include owning stock in a company that competed with a firm with a drug under review, or receiving funding from a pharmaceutical company for lectures or for research.

Rep. Maurice D. Hinchey (D-N.Y.), author of the amendment, said outside advisors with ties to the drug industry undermined the integrity of the agency’s decision-making. Under his amendment, the FDA would be forbidden to waive conflict-of-interest rules.

Hinchey said the passage of his amendment over the opposition of House Republican leaders was a sign that Congress was ready to act, though it was unclear whether a similar provision would make it through the Senate.

In the other development, a scientific panel opened an examination of the nation’s system for monitoring the safety of prescription drugs.

The FDA has been accused of being slow to respond to dangerous side effects from painkillers, antidepressants and other drugs.

Adverse reactions to medications cause an estimated 100,000 deaths a year, but the FDA’s surveillance system is only able to catch a fraction of the problems, agency officials told the Institute of Medicine panel. The institute is part of the National Academy of Sciences, which provides independent advice to government on a broad range of technical subjects.

The inquiry, expected to take a year, will result in recommendations that could include new powers and funding for the FDA, better technology to identify health problems caused by drug side effects, and changes in the way doctors, pharmacists and patients communicate about the risks and benefits of medications.

Most of the panel’s 15 members come from academia, but the two co-chairs have senior-level Washington experience, representing both sides of the political aisle.

Sheila Burke was for years the top healthcare policy aide for former Senate Republican leader Bob Dole of Kansas. Dr. David Blumenthal served as a staff member for Sen. Edward M. Kennedy (D-Mass.) when Kennedy headed a subcommittee on health and scientific research.

The FDA hopes the panel will produce a consensus blueprint for reforms. But Congress may not be willing to wait a year. Several lawmakers are pressing ahead with legislation to create an independent safety office within the agency and to make other changes.

Making the FDA’s problems worse is that the agency has been without a permanent commissioner for more than a year.

“An acting commissioner simply lacks the mandate for action that comes through the constitutional process of nomination by the president and subsequent confirmation by the Senate,” said Enzi, adding he had “full confidence” in Crawford.

In the investigation into allegations of personal misconduct by Crawford with a subordinate, Enzi released a letter from Deputy Inspector General Michael E. Little summarizing the results. The name of the subordinate was withheld for privacy reasons.

Investigators examined more than 5,700 e-mails between Crawford and the subordinate but found no evidence of an affair. Both submitted signed statements denying they were romantically involved, and interviews with other people failed to produce evidence to the contrary.

Investigators found evidence of a “collegial” relationship between Crawford, 67, and the much-younger subordinate.

But investigators also said they found evidence suggesting Crawford had helped the subordinate win a promotion and inconsistencies in their explanations of what had happened, Little wrote.