Vermont Attorney Lawyer

Congress tonight a new charter for the Food and Drug Administration, the speed of approval of prescription medicines.The chief negotiators in the House and Senate also said they had on radical changes in adopting a child.

President Clinton is expected to sign the two bills. The F.D.A. Action, a product of three years working on Capitol Hill, was the voice vote of the Senate, then in plenary.

On Saturday, confirmed by the Senate, Mr. Bill Clinton’s nominees for the execution of the disease, programs Medicaid and welfare.

The votes came at the last minute, leaving the activity as legislators have expired at the end of the first meeting of the 105 Congress.

The F.D.A. Bill bipartie a compromise was reached after the return of many Republicans across their initial proposals to relax federal government regulation of medicines and medical devices. Some previous proposals, the deadlines for FDA action, with the marketing of certain new drugs automatically admitted if the Agency does not meet the deadlines.

Senator Edward M. Kennedy, Democrat of Massachusetts, led the opposition to the root of many Republican proposals. He welcomed the final agreement today Abend”als a victory for public health, for patients and for industry.”

Mr. Kennedy attacked several proposals, which he saw as a weakening of the authority of the FDA’s regulation of medical devices.

Senator James M. Jeffords, the Vermont Republican, is the chairman of the Committee on Labour and Human Resources, said the bill, the main changes made in resolving the active substance in three decades.

Alan F. Holmer, president of the Pharmaceutical Research and Manufacturers of America, a trade association for pharmaceutical companies, welcomed the final agreement. In an interview, he said that shaving the bill would be at least one year before the deadline through the discovery of a new drug laboratory after its arrival within the family medicine chest. The average duration is currently 12 to 15 years, “said Holmer.

B. Joan Claybrook, president of Public Citizen consumer group founded by Ralph Nader, a single voice criticizing the bill tonight. She said that sie”reduziert the authority of the FDA to protect consumers.”

The final decision of the Bill would make new procedures to expedite the admission of drugs for the treatment of der’’schweren or death.”Such procedures have already accelerated approval of drugs for people with AIDS and the virus that causes AIDS.

Normally, a company seeking approval of the drug for a new product must show that patients, it allows you to live longer or reduce their symptoms. According to the bill, which F.D.A. could benefit the effectiveness of alternative measures - shrinkage of the tumor, for example, or reduction in the amount of virus in the body of a patient - indicating that the clinical benefit of drug east.

One of the issues in the negotiations was the use of drugs, whose approval by the Government to serve a purpose, but they are widely prescribed and used for other purposes. These off-Label””verwendet for medicines prescribed for more than 90 percent of all cancer therapies, “said Holmer.

Under current law, drug trafficking in general, companies may not circulate information on the unauthorized use of their products, unless a doctor calls in particular the data. According to the compromise, manufacturers could circulate texts prestigious magazines health professionals to support the use of drugs not approved for the purpose fulfilled, if they meet certain conditions.

For example, the F.D.A. would have an opportunity to review texts, and if the materials were nicht”objektive and balanced,”the government to ask the drug could be undertaken as opposed to actions or additional information with doctors and insurance. In most cases, the manufacturer would also permit federal research on drug-Off would Label””verwenden and implementation of research that are necessary to justify such an authorization.

Similarly, the government has the ability to verify the safety of medical products are likely to be used for purposes which are not within the FDA and the agency may require companies to disseminate warnings on the aircraft, when they expect what products are used for a solche”off label”Zwecke.