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by Justin Haskins and Michael Hamilton
While Republican presidential candidate Sen. Ted Cruz of Texas fights on the campaign trail, he and Sen. Mike Lee, R-Utah, are waging a battle in Washington, D.C., over potentially life-saving legislation that would radically transform the approval process for drugs and medical devices.
The Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 (RESULT Act) would fast-track drug and medical device applications through the Food and Drug Administration’s sluggish and costly approval process. The act would streamline new products already vetted by a government agency in another Organization for Economic Cooperation and Development nation with a proven record of providing safe medical devices and pharmaceutical products.
Under the current regulatory scheme, the FDA must approve drugs and medical devices before U.S. patients may use them, regardless of how widely those products are used in other advanced nations around the world. This process is typically long and costly. According to a 2013 study by Forbes, pharmaceutical companies spend about $350 million for a new drug to be developed and approved for sale in the United States. Worse, because many drugs fail to make it onto store shelves, Forbes estimates drug development costs pharmaceutical companies $5 billion per new medicine.
Drug companies pass these tremendous costs on to insurance companies, which pass them on to consumers. This is one reason many drug prices start out so high, and it’s a contributing factor to the rising prices of once-inexpensive generic drugs, such as the antibiotic tetracycline, which experienced a 7,567 percent price increase from 2013 to 2015. As regulatory costs for newly created pharmaceuticals rise, drug companies are forced to earn higher profits from their other products.
U.S. patients are often stuck waiting years for drugs and medical devices that could treat their illnesses, while patients in other nations have been safely using those same products for years.
The RESULT Act would help resolve these two problems — expensive development and long waits — by requiring the secretary of the Department of Health and Human Services to approve certain applications within 30 days. The bill fast-tracks approval for products that would help alleviate a public health need, are approved by a trusted government agency in one of the bill’s listed nations, and which current FDA regulations do not already ban. Congress also would have authority under the RESULT Act to approve with a majority vote any application the FDA rejects.
Opponents of the legislation say the FDA is the most trustworthy agency for drug and medical device approvals in the world, so it would be dangerous for Americans to rely on the approval of foreign agencies. Rachel Sachs, an academic fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, wrote in December that the FDA’s slow-moving approval process is a “virtue, not a vice,” pointing to a decision by the FDA in the 1960s to reject the use of thalidomide, which turned out to be dangerous, despite the drug’s approval in many European countries.
Sachs is right to point out the FDA’s strong track record, but she and other opponents of the RESULT Act say nothing about the lives lost, ruined, or significantly harmed while sick Americans wait for drugs and medical devices that have already been tested countless times in other nations and are proven safe. Sachs and others have even acknowledged foreign nations’ regulatory agencies, including the European Medicines Agency and the Health Products and Food Branch in Canada, take longer on average to review new drugs than the FDA does. If moving slowly in the drug and medical device approval process is a “virtue,” then aren’t longer approval periods in EMA and HPFB evidence of the high quality of these agencies’ findings?
If FDA is concerned a product approved by another trusted government agency in a foreign nation is not safe, it should announce a warning and leave the trained medical community to decide for itself. Doctors, not bureaucratic agencies, should have the authority to decide which medical services, devices and drugs are safe to use, especially when governments in other advanced parts of the world have already approved them.
The RESULT Act would help reduce prices of new and existing drugs and medical devices, and lower the time required for FDA approval, allowing U.S. patients to have improved access to life-saving or life-improving medical products already enjoyed by people around the world.