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US may tighten guidelines on drug approvals


US regulators are considering tighter guidelines for the approval of some drugs, making some of the world's largest pharmaceutical companies rethink their research efforts.

The Food and Drug Administration, the powerful healthcare regulator that approves prescription drugs before they are sold in the US, has told the industry it plans to tighten the standards for antibiotics and other treatments for infections.

The FDA says it hopes the guidelines will stimulate the development of more innovative medicines as well as addressing growing public concerns over drug safety.

However drugs companies, already facing reduced returns from their heavy research programmes, believe the new rules could increase the cost of clinical trials and discourage investment in antibiotics. Drugs currently under development could be discontinued, they said. The FDA says it may tighten the standards on submitting drugs for approval. For example, a new antibiotic might have to compare much more favourably with existing treatments than was required in the past, before the FDA would consider it.

Dr Sandra Kweder, acting director of the FDA's Office of Review Management, said any change in rules "would raise the bar for them in demonstrating a drug's effectiveness. That could mean more investment in trials."

The FDA had been due to hold a public meeting on the issue in September, which was postponed until early next year after the terror attacks. No final decision had yet been made on tightening guidelines for drug submission, she added.

The potential rule changes have become even more controversial since the start of the anthrax outbreak in the US, which has served as a reminder of the continuing importance of antibiotics.

Some drugs industry executives said the proposed rule changes would encourage companies to reduce investments in antibiotics. They also fear other therapeutic categories could face similar restrictions. "You often do not know how a drug will really perform compared to its competitors until it has been on the market for a while," said one executive at a US group. "This will force us to have much larger and more expensive clinical trials."

Despite breakthroughs in science, the industry is facing a sharp decline in its productivity. In 1996 the FDA approved 53 new molecular entities - potential medical breakthroughs - while 27 passed last year and only nine in the first half of this year. The FDA, which has been without a leader since President George W. Bush sacked its director in January, has already come under intense criticism from the industry that it is slower and more cautious in approving new drugs. The regulator rejects the claims.

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