U.S. to Speed Up Release of New Cancer Drugs

The federal government will take new measures to speed up release of promising experimental cancer drugs to the public, a move expected to shave years from the often-lengthy process, President Clinton said Friday.

“There is hardly a family in America who has not been touched by cancer,” said Clinton, who lost his mother and stepfather to the disease. “We have come a very, very long way in the fight against cancer. More people are survivors than ever before. But we have a great deal more to do.”

The announcement comes at a time when Republicans in Congress and elsewhere are calling for reform of the Food and Drug Administration, in part because they believe that the agency is sluggish in approving drugs. The pharmaceutical industry has joined in those criticisms and also complained that the process is unnecessarily costly.

Clinton, noting that cancer drugs often take years to reach the market, said: “I am happy today to say to those patients and to their families [that] the waiting is over.”

The new initiative will affect at least 100 drugs now under study, he said. “Dozens of them will get to the market sooner and that means they can help Americans suffering from cancers of the breast, lung, ovary, prostate and colon, among others.” Clinton’s mother, Virginia Kelley, died of breast cancer.

Cancer is the second-leading killer of all Americans, after heart disease, and will strike an estimated 1.3 million Americans this year. An estimated 554,740 deaths--one in four in this country--will be caused by cancer.

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The new initiative, based on a model that has been used in recent years with AIDS therapies, will allow new drugs to be approved by the FDA on earlier evidence--in this case, shrinkage of tumors--rather than the traditional end points of increased survival time or improved quality of life.

“We will be making initial decisions based on less information” and the result could be riskier for patients, said FDA Commissioner David A. Kessler. But often cancer patients, like AIDS patients, “are willing to take those risks,” he said.

The FDA will also take additional steps to provide Americans greater access to cancer drugs that have been approved overseas but have yet to be licensed in this country, Clinton said. This has been an issue dogging the FDA.

The agency will encourage manufacturers of drugs approved abroad to seek agency permission to distribute those drugs to eligible cancer patients in the United States before they are licensed here.

The agency always has had the authority to allow such so-called “compassionate use” of unlicensed drugs but has never actively urged manufacturers to ask for it. The provision enables cancer patients, many of whom have no other therapeutic alternatives, to take unapproved drugs.

“We want to provide access,” Kessler said.

In addition, agency officials said that they will include cancer patients on all FDA advisory committees that deal with cancer drugs.

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“These committees play a major role in policy and product decisions, and cancer patients who have valuable insights and the most at stake should be at the table when these decisions are made,” Clinton said.

The FDA, in another change, will make it easier for drug manufacturers to study other uses for already approved cancer drugs by reducing the required paperwork in applications, Clinton said.

“By cutting out these unnecessary applications, we will free investigators from paperwork and allow them to devote more time to cancer research,” Clinton said.

Clinton’s announcement came one day after the Senate Labor and Human Resources Committee approved legislation aimed at stepping up the agency’s review process for new drugs and medical devices. Health and Human Services Secretary Donna Shalala insisted, however, that the administration’s work on this issue “started long before the current reform efforts” in Congress and was part of its own internal reform project that has been headed by Vice President Al Gore.

Clinton, surrounded by representatives of cancer patient advocacy and education groups, made the announcement from the White House accompanied by Kessler, Shalala and Gore, whose sister died of lung cancer.

“I don’t think anybody who has cancer wouldn’t be delighted to see the president of the United States paying so much attention to this issue,” said Ellen Stovall, executive director of the National Coalition for Cancer Survivorship, who was present for the announcement. “It’s a long overdue issue that expands on something we all want.”

In the past, a drug gained approval only after research had proved that it either could cure a disease or significantly extend life. Typically, such trials--which are conducted in phases that add increasing numbers of patients--took years, and were followed by an FDA review that added additional time.

But in 1991 under Kessler, the FDA established a mechanism known as “accelerated approval” to license experimental drugs faster for life-threatening conditions or serious disorders for which there were no existing therapies.

The mechanism allows a drug onto the market based on the results of research showing early evidence that may be predictive of clinical benefits. But the statute also requires further post-marketing studies to prove that the drug provides such benefits.

In the case of AIDS, for example, drugs have been licensed based on increases in a patient’s CD4 immune system cells, the primary target of the human immunodeficiency virus, or on decreases in the amount of measurable virus in a patient’s bloodstream.

Approvals often came without knowing definitively whether these signs would translate into longer life for patients or enable them to suffer fewer AIDS-related infections.

But the drug must also be proven effective and safe. It can then be quickly taken off the market if it proves dangerous or ineffective.

“In the end, we will require the same information,” Kessler said. “Thus far, we haven’t made a mistake.”

Accelerated approval has been given to 11 drugs since 1991, most of them for AIDS.