The survey found that under the pressure of legislators and the Trump government, the agency's drug review was speeding up.
Between 2001 and 2010, 71 (32%) of the 222 new therapeutic agents approved by the agency had a safety event with a median of 4.2 years. The safety incident evaluated in the study marks any of the three FDA actions: the complete withdrawal of the drug from the market; the addition of a boxed warning to the drug label, which is usually added to life-threatening health risks; or Issued a secure communication, which is a serious but not life-threatening health risk.
In general, the agency withdrew three drugs *, fitted with 61 boxes of warnings and issued 59 safety briefings.
Researchers led by Joseph Ross, a professor of medicine and public health policy at Yale University, want to analyze drug features that can help regulators identify health risks that may be hidden at the time of the review. This may allow regulators to intensify their scrutiny, increase postmarketing, or improve the sharing of data for certain drugs.
Ross and his colleagues said: "The vast majority of key trials that form FDA-approved baselines have reported fewer than 1,000 follow-up patients in 6 months or less, which may be associated with the identification of rare or long-term severe safety hazards Challenge. " "High frequency post-market security incidents underscore the need to continuously monitor the safety of new therapeutic drugs throughout its life cycle."
However, the study may also provide some policies that may come from accelerating the FDA's quick review.
In his first speech to Congress, President Donald Trump said the FDA's review process was "slow and heavy." He vowed to "cut the limit" in the institution. However, the FDA is growing faster than recent history. Since the 1992 Congress passed the Prescription Drug User Fee Act, the FDA has allowed review fees from drug manufacturers, and the review time has steadily declined. In 2016, the median of the standard review fell to about 10 months, down from about 27 months in 1993.
Last month, Ross and his colleagues (Nicholas Downing, of the Brigham and Women's Hospital, and Jane Zhang of the New York University School of Medicine) reported in the New England Journal of Medicine that the FDA averaged more than two months later European Drugs, European Medicines Agency.
Unsafe comments
In their new study, researchers expect to see how the speed of approval and other factors affect the security of the market. First, the "biological agents" (ie, drugs consisting of complex combinations of sugar, protein, live virus, cells, tissues or substances) are more likely to cause postmarket safety than "drugs" (drugs made from small molecules) The In addition, in different treatment categories, psychiatric drugs are most likely to have post-market safety events compared to other drugs for the treatment of cancer and blood diseases.
When the approval time, the result is a bit complicated. FDA-approved drugs are more likely to have post-market safety issues before the deadline for review. On the other hand, the fastest approved (200 days) of the drug is unlikely to have a security problem in the future. The author interprets this as implying that if the drug has strong pre-market safety data and can be reviewed, it may be a good indicator of its overall safety. And when their comments hang up in drugs, it may be because regulators are trying to solve weak or safe data in the pre-market, which could be a red flag, indicating a pre-market security issue.
