A research study conducted by Yale University researchers has determined that 32% of FDA approved drugs have safety issues. The study has been published in the May issue of The Journal of the American Medical Association.
While many of the safety issues found do not warrant removal from the marketplace, the researchers noted that their findings underscored the need for continued monitoring of pharmaceuticals even after they’ve been approved for market use.
“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.”
President Trump has supported accelerating the approval process by eliminating some of the testing procedures. 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.
However, consumer safety advocates have warned that such deregulation could be dangerous and harmful to consumers who rely on the government to ensure safety and effectiveness of the approved drugs.
“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.”
Deregulation of the drug approval process doesn’t help consumers. It only serves to increase the profits of huge pharmaceutical companies who are already making profits at a record pace. This isn’t good policy but a reckless bow to the drug companies.
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