Perspectives: FDA Needs To Demand More From The Drugs It Approves

The New York Times: Easier Drug Approval Isn’t Cutting Drug Prices
Dr. Scott Gottlieb, the commissioner of the Food and Drug Administration, recently vowed to bring “new science” to market faster, in hopes that patients benefit from treatment advances sooner. 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. (6/8)

Bloomberg: The World Can’t Afford High-Tech Insulin
The researchers who pioneered insulin injections for diabetes sufferers in 1922 were dedicated to making the life-saving treatment widely available, and gave away their rights to profit from the discovery. Yet almost a century later, the medicine is still beyond the reach of roughly half of the 100 million people around the world who need it. Governments should be asking why, and doing something to put this right. Insulin is still expensive because the three major producers — Novo Nordisk, Eli Lilly and Sanofi — have been granted patents on the drug as they have incrementally changed it. First they derived the hormone from animals, then from humans, and most recently from recombinant DNA techniques. With each small advance, the price has gone up. (6/7)

Forbes: Amazon Could Still Disrupt The Prescription Drug Market
While list prices of drugs in the U.S. continue to grow at an annual clip of around 6%, real or net U.S. drug prices, including discounts and rebates, fell 5.6 percent in the first quarter of 2018. Pharmacy benefit managers (PBMs) appear to be successfully lowering net prices of drugs through higher rebates and co-payment accumulators. But, end-users continue to be feel the pain of higher cost-sharing, premiums, and deductibles.Because PBMs do not disclose rebate information, consumers cannot effectively determine if their PBM is favoring drugs with the lowest net out-of-pocket cost. The PBM may in fact be favoring drugs with a higher list price due to the rebates or claw backs it is earning. And, because the increasingly prevalent form of patient cost-sharing is co-insurance, out-of-pocket costs to consumers are increasing. (Joshua Cohen, 6/8)

Bloomberg: Blockbuster Drugs? How About Doing More With What We've Got
When it comes to innovation in health care, it's easy to focus on potential blockbuster drugs that hold the promise of flashy cures with billion-dollar sales potential. But a growing crop of research suggests there are also gains to be made by better using drugs we already have. Case in point is a study published earlier this month in the New England Journal of Medicine, which found that women who have breast cancer with certain genetic characteristics can take hormone therapy alone  and avoid chemotherapy. The findings are encouraging, and not just because of the positive impact they will have on patients who may be able to bypass the toxic side effects of chemo. They also offer broader takeaways about best practices for shaping the direction of medicine. (Max Nisen, 6/8)

Forbes: Pharmacy Benefit Managers Are Not The Cause Of High Prescription Drug Prices
The press has found no shortage of villains for the high cost of prescription drugs today. While the pharmaceutical companies typically receive the lion’s share of the blame, of late the Pharmacy Benefit Managers have come under fire for their supposed role in high drug prices. Pharmacy Benefit Managers work on behalf of health insurance companies to help them negotiate prices with the pharmaceutical companies, and the price breaks they obtain typically come in the form of rebates paid to the companies. (Ike Brannon, 6/6)

The Roanoke Times: Virginians' And Americans’ Drug Prices Are Rising. Here’s A Major Reason.
Congressional lawmakers just held a hearing to figure out who’s responsible for surging drug prices. No one could point to a single culprit. But Virginia Rep. Morgan Griffith (R-VA) correctly pointed to pharmacy benefit managers (PBMs) as an obscure but critical offender. “I can’t for the life of me figure out what you do,” he said to a PBM lobbyist. “[But] we’ve got this black box called a PBM ... and they [the pharmaceutical companies] are saying they’ve got to raise their prices to pay you.” PBMs negotiate, manage, and administer prescription drug benefits for health insurers as well as self-insured companies, working between drug companies and pharmacies. They are the middlemen who are involved in every step of the drug supply chain. (Harry L. Gewanter, 6/11)