June 8, 2018 | The New York Times
Easier Drug Approval Isn’t Cutting Drug Prices
Medications are already clearing regulatory hurdles faster than ever, but it’s not clear that people, as opposed to drug companies, are feeling much benefit. For several years the F.D.A. has been lowering the standards by which it decides whether new medications are safe and useful. The agency now requires fewer and smaller clinical trials, approving some drugs after just one successful trial. It also accepts short-term effects (like whether a drug shrinks a tumor) instead of clear clinical outcomes (like whether the drug prolongs life), and ever-smaller improvements in health as sufficient proof that a medication works and is worth selling.