Congress Approves NCI Appropriations, Passes FDA Reform Act

WASHINGTON—In the waning weeks of the 1997 congressional session, the House and Senate passed, and President Clinton signed, several pieces of legislation of significance to the oncology community, including the National Cancer Institute appropriation bill and the Food and Drug Administration “reform act.” But the Congress left some tough issues, including legislation to implement the proposed tobacco settlement, until it returns in 1998.

Both the National Institutes of Health and the National Cancer Institute won boosts in their budgets well above the inflation rate. NIH’s overall funding for fiscal 1998, which began Oct. 1, went to $13.647 billion, an increase of $907 million, or 7.1%, over fiscal 1997. The final number, worked out in a drawn-out conference committee that resolved differences between the appropriations bills passed by the House and Senate, fell between the Senate’s 7.5% increase and the 6% hike initially approved by the House.

The NCI’s fiscal 1998 budget rose a little more than $158 million, or 6.6%, to $2.547 billion. The Senate had approved an increase of 7.1% and the House had okayed a 5.2% hike.

Although the conference agreement did not set a specific amount for NIH-funded AIDS research, the committee’s report did note an understanding that NIH would spend $1.595 billion on such work. In addition, the appropriations bill provided $40.536 million to fund the office of AIDS research within the NIH director’s office.

Congress boosted the FDA’s budget to $1.03 billion, up $35 million from fiscal 1997, $105.2 million of which will come from fees paid by drug and medical device makers.

And after resolving a divisive issue regarding the regulation of medical devices, Congress also passed the FDA “Modernization and Accountability Act of 1997.”

In addition to streamlining the way FDA approves new drugs and medical devices, the bill makes it easier for seriously ill patients to obtain experimental drugs, sets up a fast-track system for approving medications for life-threatening diseases, renews the 5-year-old “user fee” system for pharmaceutical companies, and allows companies to provide certain information about “off-label” uses of their products.

Under the new law, manufacturers of drugs, biological products, and medical devices may provide a variety of health care professionals, insurers, benefit managers, and federal and state agencies certain “written information concerning the safety, effectiveness, or benefit of a use not described in the approved labeling of a drug or device.”

Sen. Connie Mack (R-Fla), a key sponsor, said that the provision will allow dissemination of “the best scientific information available on new uses of pharmaceutical drugs and medical devices.”

Renewal of User Fee System

The FDA legislation also provides for a 5-year renewal of the user fee system. Under it, pharmaceutical companies pay extra fees so that the FDA can hire more reviewers and speed up the drug approval process. In the 5 years since its inception, these companies have paid the FDA some $327 million, according to the Pharmaceutical Research and Manufacturers of American, which estimates that amount will reach about $600 million in the coming 5 years.

The new measure also directs FDA to establish a toll-free telephone number so that physicians and patients with life-threatening diseases can find out quickly what clinical trials patients might enter.

“Facilitating access to this information can help doctors and their patients with diseases such as cancer, Parkinson’s, and Alzheimer’s learn about research underway and can expand the pool of research participants,” said Sen. Dianne Feinstein (D-Calif), who co-sponsored the provision.

The FDA bill won approval after a House-Senate conference committee resolved a conflict regarding how much power FDA would have over the marketing of medical devices. A Senate provision would have prevented the agency from testing medical devices for uses other than those the manufacturer claimed on its labeling, a restriction that led to threats of a presidential veto. The new law gives FDA the power to investigate devices for all marketed purposes.

Tobacco ‘Windfall’ Repealed

Congress also repealed a potential $50 billion windfall for the tobacco industry included in the tax-cut bill passed last summer. That provision would have allowed tobacco companies to write off $50 billion of the $368.5 billion they would pay in the proposed tobacco settlement.

This amount equals the estimated revenue that a 25-cent-a-pack cigarette tax increase included in the tax-cut bill will raise over 25 years. “The tobacco industry must understand Congress will no longer do its bidding,” said Sen. Richard J. Durbin (D-Ill), a leader in the repeal effort.

The House and Senate also barred the use of federal funds to promote American tobacco products abroad and restricted federal employees from contesting the health regulations of other nations designed to reduce smoking. This measure “reflects a clear, ethical, national policy consistent with how we want our own children protected,” said Rep. Lloyd Doggett (D-Tex), the provision’s sponsor.