FDA program unintentionally causes price hikes

Several drugs — medicines that are on the market, ready to be prescribed — are still unapproved. That’s because they came into being before the current regulatory practices were set in place — so they were simply grandfathered in, without much scrutiny. The FDA, in response, launched the Unapproved Drugs Initiative back in 2006, in an attempt to make sure that many of these older drugs are indeed safe and effective.

But it’s come at a cost, STAT’s Ed Silverman writes. Such intense examination of decades-old drugs has prompted many companies to quit manufacturing them — allowing others to gain a monopoly and charge sky-high prices. A new study shows that just four such examples could add $20.3 billion to U.S. health care spending.

ICER validates two drug pricing choices

The Institute for Clinical and Economic Review often has a dour view of drug costs: Most new drugs are, according to the think tank, rarely worth their price tag. But in a rare move, ICER’s reversing its decision on the value of two new migraine drugs.

It’s deemed that Allergan’s Ubrelvy and another migraine medicine from Biohaven Pharmaceuticals that has yet to be released should cost between $4,150 and $4,640 per year. That’s rather close to Ubrelvy’s actual list price of $4,900 — especially considering that a previous ICER analysis suggested the drugs should cost closer to $2,200 per year. Biohaven CEO Vlad Coric, for one, said in a statement that he felt “vindicated by the decision.”

Gilead drug goes to clinical trials for coronavirus

The most potent antivirals are being studied as possible treatments for coronavirus. And remdesivir — a drug developed by Gilead Sciences to treat the Ebola and Marburg viruses — is now getting a nod of approval from the World Health Organization.

“There is only one drug right now that we think may have real efficacy, and that’s remdesivir,” a top WHO official said during a Beijing press conference on Monday. Gilead saw a 5% stock jump in response to this news.

Now, U.S. clinical trials testing remdesivir on coronavirus are officially underway in Nebraska. The first trial participant is an American who contracted the illness on the Diamond Princess cruise ship.

The FDA can't get complacent

Former FDA commissioner Mark McClellan has some sage words of advice for the agency he used to helm: Don’t get stagnant.

McClellan, along with cancer patient advocate Ellen V. Sigal, opine that there are many changes the FDA can make in the new decade. Rather than simply accelerating approvals, for instance, a major priority should be on public health — and whether the new drugs are safer or providing better outcomes for patients.

The agency should continue to encourage public opinion on how it operates, McClellan writes, and should modernize how it collects and uses digital health data. The medical field is evolving rapidly these days, after all, and their thought is that regulators need to evolve just as quickly.

FDA program unintentionally causes price hikes

ICER validates two drug pricing choices

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Gilead drug goes to clinical trials for coronavirus

The FDA can't get complacent

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