A new report commissioned by the Food and Drug Administration has found that newer medicines could hit the markets sooner if regulators met with the drug makers and apprised them of their concerns regarding that particular medication before it went into the final phase of human testing.
AdvertisementThe report by consulting firm Booz Allen Hamilton, on behalf of the FDA said that 53 percent of drug makers who met with the FDA before conducting trials had their applications approved out of a total of 77 applications received between 2002 to 2004.Compared to this only 29 percent of drug makers who did not meet up with the FDA had their medicines approved. "We have seen a pretty dramatic growth in the number of meetings we're having with sponsors in the past several years. Any additional workload for meetings is going to have to be supported by additional staffing," said Dr. John Jenkins, director of the FDA's Office of New Drugs. He added that the FDA would discuss this issue in the next meeting and would also take a note of the fees paid for such reviews. The report added that many drugs that failed to clear the first cycle were deficient in only a couple of areas and that had the FDA voiced these concerns, the companies would have been able to fix them. "Early and open communication with the sponsors will allow sponsors to address/resolve issues in a timely manner, potentially within the first review cycle," the report stressed. Dr Jenkins admitted that the communications segment of the FDA had room for improvement, but "some of the burden relies on the sponsors to make sure they understand what is being told." The report also noted that smaller companies had a tough time getting regulatory approval for their products, "Large, U.S.-based companies have the highest first-cycle approval rate, at approximately twice the rate of small biotechnology companies with no prior FDA approvals," it concluded.
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