Bill Would Ease Distribution of Off-Label Data

WASHINGTON--Nancy L. Kasse-baum (R-Kan), chairman of the SenateLabor and Human Resources Committee, expects the Committee tocomplete action in late March on her bill to reform the US Foodand Drug Administration (FDA). The bill would then be forwardedto the full Senate for a vote.

The measure, the FDA Performance and Accountability Act (S. 1477),includes a controversial section that would end the FDA policythat bans pharmaceutical companies from providing physicians withscientific reports on the off-label uses of FDA-approved drugs.

This provision was originally introduced last August as a separatebill by Sen. Connie Mack (R-Fla), Sen. William Frist (R-Tenn),a surgeon, and six other co-sponsors. It was later incorporatedinto Sen. Kassebaum's legislation.

A Kassebaum aide indicated that FDA officials have expressed concernsto committee staff about the off-label provision. "Theirmain concern is to what extent the free exchange of off-labeluses would discourage companies from doing the research necessaryto prove that an off-label use is actually safe and effective,"the aide said.

Despite the FDA's concerns, Sen. Mack expects solid support forhis provision from both parties. "The legislation is in theearly stages of a long process, but the issue is one that shouldattract bipartisan support," he said in an interview.

Rep. Richard Burr (R-NC) has introduced a similar bill in theHouse, Sen. Mack said. Should the Senate pass an FDA reform bill,it would then go to the House for hearings and action.

Sen. Mack has not withdrawn his original bill, although its provisionsare now part of Sen. Kassebaum's measure. Thus, should Sen. Kassebaum'sbill fail, Sen. Mack could continue to pursue the original Mack/Fristbill.

The Proposed Reform

Although physicians can legally administer a drug approved forone disorder to a patient with another disease for which the drugis not approved, the FDA since 1991 has barred pharmaceuticalhouses from distributing scientific articles that describe suchoff-label uses.

The proposed legislation would allow pharmaceutical firms anddevice manufacturers to distribute unabridged, peer-reviewed articlesfrom medical and scientific journals, textbooks, and similar publicationsdetailing the off-label uses of a drug or medical device.

Information from a scientific or educational program approvedby an independent body that accredits continuing medical educationprograms also could be disseminated, as could peer-reviewed dataabout drugs or devices that are recognized under federal law forthird-party coverage or reimbursement.

Companies distributing materials on off-label uses would haveto disclose that the Secretary of Health and Human Services hasnot approved the information and that the company is paying forits dissemination. The drug company would be required to identifyany authors who are employees of or consultants to the company.Finally, any material on off-label uses would be accompanied bythe FDA-approved labeling for the drug.

"It's important for physicians to have the best peer-reviewedscientific data available to consult with patients about treatmentoptions," Sen. Mack told Oncology News International. "It'ssimply wrong for the government to act as gatekeepers in decidingwhether doctors should be allowed to receive peer reviewed medicaldata."

An aide to Sen. Mack cited Schering Plough's Intron A (interferonalfa-2B, recombinant) as an example of how oncologists and patientscould benefit from the senator's off-label proposal.

"It has been approved by the FDA for the treatment of melanoma,hepatitis B, and other diseases," he said. "Additionalstudies were published in the New England Journal of Medicineand the Journal of Clinical Oncology showing that the drug iseffective for kidney cancer, multiple myeloma, and bladder cancer."

Yet under current FDA policy, the manufacturer of Intron A isprohibited from giving copies of these medical journal articlesto oncologists, the aide said.

Many Opposed to FDA Restrictions

Sen. Mack noted that a survey of 160 oncologists, released lastAugust by the Competitive Enterprise Institute, found that threequarters of the surveyed population opposed the FDA restrictionson the dissemination of off-label medical information.

"The survey is an indication that those on the frontlinesof the cancer war want the freedom to receive peer-reviewed, off-labelmedical data in order to make informed treatment decisions withtheir patients," the senator said.