February 11th, 2016|
The pharmaceutical industry has been at odds with government regulators for decades. Many of the criticisms are on the Food and Drug Administration (FDA) and the claims that the FDA approval process is too slow. The argument is this process keeps life-saving drugs from individuals who need them the most. A recently proposed bill is said to address these concerns.
Senators Ted Cruz (Texas) and Mike Lee (Utah) have cosponsored the Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act. As the name implies this law would allow reciprocal approval of drugs, devices, and biologics from foreign sponsors in European countries, as well as from Japan, Canada, Australia, and Israel. It would also give Congress the authority to overrule FDA rejections of certain life-saving drugs. In a statement about the purpose of the RESULT Act Senator Cruz implies the government, specifically, the FDA, is the primary inhibitor of medical innovation.
Senator Cruz’s point is debatable. In 2012 the New England Journal of Medicine published a report on this very issue. The authors of the report found that the FDA completed first time reviews of new medications on average 50 to 60 days more quickly than the European Medicines Agency (EMA), the drug approval regulatory agency for the European Union, and Health Canada. See N.S. Downing, et al., Regulatory Review of Novel Therapeutics – Comparison of Three Regulatory Agencies, 366 New Eng. J. Med. 2284-2293, 2289 (2012) The report reviewed 510 applications for new drugs. Id. at 2284. Of the new drug applications, 225 were approved by the FDA, 186 were approved in Europe, and 99 in Canada. Id. With drugs approved by both the FDA and Europe, the FDA approval process was actually faster than Europe. The FDA approval process on average was 96 days faster than Europe’s process. Id. at 2291. With drugs approved in both the United States and Canada the approval process was on average 355 days faster in the United States than in Canada. Id.
Pharmaceutical companies would obviously benefit financially from a quick and easy regulatory process. However, the real concern should be making sure the medications made available are not only effective but also safe. Just recently a number of widely used medications have been alleged to have harmful, unintended side effects. A few examples include Zofran and birth defects, Invokana and similar diabetes drugs potentially causing diabetic ketoacidosis, Byetta and Januvia causing pancreatic cancer, Lipitor and diabetes, and Multaq and liver failure. With such a large number of prescription drug injuries, the emphasis should not be on streamlining a system that is already the most efficient system compared to other similar processes. The emphasis should be a process that ensures the safety of individuals in need of the medications.
If you or someone you care about suffered severe side effects from a prescription medication, the experienced lawyers at Cory Watson Attorneys are ready to fight for you and are available to answer any questions you might have. Pick up the phone and call us at (877) 686-8992 or fill out a Free Case Evaluation form on this page.