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Study Finds Safety Issues in a Third of FDA-Approved Drugs

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assortment of pills and a syringe scattered on a table

Even as President Trump pushes to shorten the amount of time it takes the FDA to approve drugs for market, a new study says safety issues are discovered in nearly a third of all drugs years after they are approved by the agency.

The findings by Yale researchers were published in the Journal of the American Medical Association on May 9.  The team found that 32 percent of new drugs were the subject of safety issues after they were approved. Most of the concerns were not serious enough to require that the drugs be withdrawn, but researchers said their findings show the need for continued monitoring of new drugs after they are released.

Researcher Calls for Strong Drug Monitoring

“We seem to have decided as a society that we want drugs reviewed faster,” lead author Dr. Joseph Ross, an associate professor of medicine and public health at Yale University, told The Washington Post. That, he said, makes it imperative “that we have a strong system in place to continually evaluate drugs and to communicate new safety concerns quickly and effectively.”

The president, who spoke about the issue during the campaign, called the FDA approval process “slow and burdensome” in his speech to a joint session of Congress on Feb. 28.

Trump related the story of Megan Crowley, a young woman with a rare disease whose father founded a company to find a cure that helped save his daughter’s life.

“If we slash the restraints, not just at the FDA but across our government, then we will be blessed with far more miracles just like Megan,” the president said.

Earlier in the month, Trump met with the heads of several large pharmaceutical companies and promised to cut FDA regulations to make it easier to get drug approval, as part of his and conservatives’ overall deregulation strategy. “We’re going to be cutting regulations at a level that nobody’s ever seen before,” Trump said at that meeting.

But consumer advocates say the FDA’s approval process is already fast, and speeding it up could be dangerous.

“The fact is, we have spent the last three decades speeding up the drug approval process,” former FDA head Dr. David Kessler told NBC News. Kessler said the FDA’s process is already “the fastest in the world.”

The FDA says Americans benefit from the “safest and most advanced pharmaceutical system in the world,” overseen by the agency’s Center for Drug Evaluation and Research (CDER).

The agency says that companies wanting to sell drugs in the U.S. have to test it first in laboratories and on animals, and then on humans. Next, the companies must send the results to CDER to prove the drugs are safe and effective for their intended use. After that, the FDA says, “A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company’s data and proposed labeling. If this independent and unbiased review establishes that a drug’s health benefits outweigh its known risks, the drug is approved for sale.”

Post-Market Safety Events in New Drugs

The new study examined 222 new drugs and biologics approved by the FDA between 2001 and 2010. Biologics are products such as vaccines, blood and blood components, allergenics, gene therapy, tissues and proteins.

Of those, 32 percent were the subject of what the study referred to as “post-market safety events”:

  • Three withdrawals
  • 61 boxed warnings
  • 59 safety communications.

Some categories of approvals accounted for significantly higher rates of these events, the authors found. Those categories were:

  • Biologics
  • Psychiatric therapeutics
  • Accelerated and near–regulatory deadline approval.

FDA Process Quicker than Europe

In April, Ross co-authored a study that concluded that the FDA’s approval process is quicker than its peer agency in Europe, the European Medicines Agency (EMA). That study found that the FDA approved more new drugs than EMA between 2011 and 2015, when the FDA approved 170 drugs for market compared to 144 given the green light by EMA. Researchers found that the median review time for FDA-approved drugs was 306 days compared to 383 days for EMA-approved drugs.

That study was an update to previous work that also found that the FDA approved new medicines quicker than Canadian regulators, in addition to EMA. That earlier study found the U.S. ahead by two to three months, compared to three to four months found in the April 2017 research.

In 2014, Ross was involved in a study that showed that FDA approvals for different drugs vary widely in rigor.

“We found that during the study period, more than one-third of the drugs were approved on the basis of a single trial, without replication, and many other trials were small, short, and focused on lab values, or some other surrogate metric of effect, rather than clinical endpoints like death,” said that study’s first author and Yale School of Medicine student Nicholas S. Downing, who conducted the study with Ross and other colleagues.

Regarding that study, Ross said, “Based on our analysis, some drugs are approved on the basis of large, high-quality clinical trials, while others are approved based on results of smaller trials.”

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