In the years since the FDA accelerated its drug approval process, the black box warning rate on prescribed drugs, as well as drug withdrawals, increased, according to an article in the August Health Affairs . The Agency imposes black cash warnings to highlight the side effects that may be disabled or fatalities.
Cassie Frank, MD, a Medicine Instructor at the Cambridge Health Alliance in Massachusetts, and colleagues analyzed the history of 748 new drugs approved by the FDA between 1975 and 2009.
Compare the Records of approved before and after the 1992 passage from the Prescription User (Pdufa) Law. This law allowed the FDA to collect pharmaceutical companies rates to be paid by resources needed to accelerate the drug approval process. Pdufa has been renewed four times since 1992.
of the new drugs approved throughout the period, 114 (15.2%) received one or more black cash warnings, and 32 (4.3%) were removed from the market for security reasons.
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In total, label changes for all black box warnings, as well as withdrawals reached 208 (27.8%). Half of the warnings was issued within 12 years of approval, and half of the withdrawals happened within 5 years of approval.
The researchers found that drugs approved after the promulgation of the Pdufa were more likely to be withdrawn or a black box warning. The rate of warning or withdrawal rose from 21.2 per 100 drugs before the pdufa to 26.7 per 100 later.
"new drugs have a unique chance of acquiring a new black box warning or being withdrawn for security reasons within twenty-five years of approval," concluding researchers.
"We believe that the final solution is stronger from stronger drug approval patterns. In the provisional, with the rare exception of truly innovative therapies, doctors should preferably prescribe medicines that have been in the market more time and Therefore, they have a more established history of security. "
The FDA issued a two-paragraph instruction in response to the article: "Pdufa increased the pre-market review and created a modern post system drug security that follows the products throughout your life cycle. Specifically, PDUPA provides FDA revenue to hire additional reviewers and support staff and update your information technology systems to maximize application revision process efficiency For new medicines and biological products without compromising high standards of the FDA for approval.
"In addition, Pdufa funding has helped FDA modernize and transform the post-market drug security surveillance system. It helped drug security after being approved while remaining in the market and increased the surveillance capacity of FDA drug security. The FDA was able to adopt new scientific approaches and improve the usefulness of existing tools for the detection and prevention of adverse events, including obtaining access to the best databases available to better analyze medication security signals. "
Similar, Robert Zirkelbach, senior vice president of communications for pharmaceutical research and manufacturers of America, emphasizes the benefits of the updated system.
"Before 1992, the drug review process was unpredictable, late behind other countries and stopping patient access to new critical drugs," he says in a statement. "Providing the FDA with stable and consistent financing, the Pdufa revolutionized the process [drug review] and strengthened the high standards of security and efficacy of the agency."
It continued: "Since its promulgation in 1992, PDFAFA access to the patient to more than 1,500 new medicines, including treatments that combine some of the most lethal diseases of our nation. When injecting greater consistency, transparency and predictability in the process of medication review, Pdufa played a crucial role in improving public health. "
To improve people's safety, researchers suggest several actions that could be taken.
For example, doctors and patients may consider whether a new drug is a "advance", and consider alternatives if it is not. A symbol on labels or marketing materials can identify newly approved drugs. And the FDA could focus more on doing follow-up studies on drugs available, seeking any side effects that did not appear while drugs were being reviewed for approval.
. . Wolfe, MD, founder and senior counselor in the health research group, public citizen, Washington, D.C. "This was certainly one of the Pdufa purposes, but the failure to actually treat these two drug groups [advance and non-advance] different is what the problem is.""I would like to say that the main mission of the FDA is to ensure patient safety," says Frank. "Our study increases concerns about how well the FDA is doing this. The FDA needs to make sure that drugs are safe before they are approved, do not rush to the trial in order to meet artificial deadlines. Meanwhile Doctors and patients should avoid new drugs, especially when older drugs are available. "
