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Fda Outlines Plan To Privatize Some Agency Functions But Some Worry That Dollars, Not Safety, Will Drive Decisions

Lauran Neergaard Associated Press

The Food and Drug Administration is turning part of its job over to private companies in an attempt to speed new medical devices to American patients, officials said Thursday. But senators said that’s not nearly enough reform.

“We need a sense of urgency, we need a commitment, we need a passion for change, and if not, I think the Congress is going to roll right over you,” Sen. Barbara Mikulski, D-Md., warned FDA Commissioner David Kessler.

A package of FDA reforms announced by the White House on Thursday would save medical industries $500 million a year in regulatory costs.

The changes make it easier for companies to export therapies that aren’t approved for sale here and to get FDA approval for medicines tested abroad and those given just one major trial in people, instead of multiple testing. Also, the FDA would begin approving genetically engineered drugs before companies build the full-scale plants to produce them, and thousands of low-risk medical devices could be sold without any FDA inspection.

But the biggest change is a two-year experiment to see if private firms can do part of the FDA’s job faster than the government.

FDA critics say the agency takes too long to approve new treatments. They have clamored for the United States to copy Europe, where government-accredited firms decide whether new medical devices, from X-ray equipment to heart valves, can be sold.

The FDA’s pilot program won’t go that far. The FDA will accredit companies to decide whether certain low-risk medical devices, such as laboratory cholesterol tests and electronic stethoscopes, are safe and effective.

The FDA retains the final say, but is expected to quickly follow the outside reviewers’ decision unless it finds evidence that the devices shouldn’t be used. If the experiment succeeds, private companies might be allowed to review other FDA-regulated products.

Consumer advocates said the plan is dangerous.

Private firms “may be making decisions based more on who fills their pocketbook than what is best for the public health,” said Dr. Sidney Wolfe of Public Citizen, a consumer watchdog group.

But critics said the FDA isn’t going far enough.

The FDA reforms are “common-sense and, in some cases, long overdue first steps,” Sen. Nancy Kassebaum, R-Kan., told a Labor and Human Resources Committee hearing. “More profoundly, basic change must occur in the very way that the FDA sees its mission.”

Sen. Judd Gregg, R-N.H., accused Kessler of delaying lifesaving medicine for Americans.

“I don’t know of a drug today that is an important therapeutic advance, that could be lifesaving, that we are holding up,” Kessler responded.

But, he added, “we are also a regulatory agency … and sometimes when you’re a regulatory agency, you have to say no, the data’s not there” to support a new medicine.

Gregg said Americans don’t know about delays because companies are too afraid of FDA retaliation to speak up.

Kessler said he was bewildered by such allegations, but added: “There’s no excuse for an environment or culture of confrontation.”

MEMO: This sidebar appeared with the story: FDA REFORMS Some reforms to speed new therapies to market: A two-year pilot program to see if private companies can determine the safety and effectiveness of certain low-risk medical devices faster than the FDA, although the agency retains the final decision. Ending a requirement that makers of genetically engineered drugs build a full-scale factory before the drugs are approved. Ending FDA review before drugs and medical devices not approved for sale in the United States can be exported to countries that have approved them. The FDA says it has never blocked an export, so the rule was unnecessary. But it is federal law, so Congress must formally adopt this measure; legislation already has been introduced. Exempting an additional 125 categories of very low-risk medical devices, such as dermatology lasers and oxygen masks, from any FDA review. The FDA already has exempted 440 categories. Harmonizing FDA standards with international medical standards so the FDA can accept drugs tested abroad instead of insisting they be rechecked in Americans. Accepting a single major clinical trial as evidence a drug works, something the agency has already done on occasion. Reducing or eliminating requirements for companies to get FDA approval before improving the way they manufacture products.

This sidebar appeared with the story: FDA REFORMS Some reforms to speed new therapies to market: A two-year pilot program to see if private companies can determine the safety and effectiveness of certain low-risk medical devices faster than the FDA, although the agency retains the final decision. Ending a requirement that makers of genetically engineered drugs build a full-scale factory before the drugs are approved. Ending FDA review before drugs and medical devices not approved for sale in the United States can be exported to countries that have approved them. The FDA says it has never blocked an export, so the rule was unnecessary. But it is federal law, so Congress must formally adopt this measure; legislation already has been introduced. Exempting an additional 125 categories of very low-risk medical devices, such as dermatology lasers and oxygen masks, from any FDA review. The FDA already has exempted 440 categories. Harmonizing FDA standards with international medical standards so the FDA can accept drugs tested abroad instead of insisting they be rechecked in Americans. Accepting a single major clinical trial as evidence a drug works, something the agency has already done on occasion. Reducing or eliminating requirements for companies to get FDA approval before improving the way they manufacture products.