Commentary: ‘Right to try’ solves no actual problem

Bypassing FDA oversight could expose some to medications that are risky and ineffective.

By Bloomberg editors

Now that President Donald Trump has signed his long-sought “right to try” law, Americans have a dubious new freedom to bypass the drug quality-control system and experiment with medicines of questionable safety that may or may not work.

This solves no real problem. The Food and Drug Administration has long granted access to medicines that are only partway through the U.S. approval process for patients in extreme circumstances who might benefit. But a myth had spread throughout the land, promulgated by conservative groups, that dying patients were being refused permission to try experimental drugs. Congress responded with a feel-good law.

From now on, these patients — in fact, practically anyone who has been diagnosed with any life-threatening disease or condition, whether or not he or she is near death — will be able to choose to trust doctors and drug companies alone to look out for their well-being.

ADVERTISEMENT
0 seconds of 0 secondsVolume 0%
Press shift question mark to access a list of keyboard shortcuts
00:00
00:00
00:00
 

That’s a questionable privilege — and not just because it’s risky. Before they exercise their right to try, patients will have to persuade the companies to provide the drugs. The new law doesn’t compel the companies to so, and often they don’t want to.

Indeed, this, not FDA red tape, has been the main reason that people have had trouble getting a hold of experimental medicines. And it’s no wonder that the firms are reluctant, given that such drugs have passed only preliminary safety testing, and are far from the point of being mass-produced or priced. Most of them never will be. Only a small fraction ever get approved.

Under the new law, without the FDA’s expert guidance, companies will have even more reason to turn down requests for experimental medicines. Those inclined to provide the drugs, if they’re wise, will continue to do so only through the FDA’s existing channel — as Janssen Pharmaceuticals has decided to do. The company says that the FDA may be “uniquely aware” of available safety data.

FDA Commissioner Scott Gottlieb has pledged to carry out the new law in a way that promotes access and protects patients. But he has no authority to do anything except issue guidance and receive annual summaries from companies providing investigational drugs.

A word of advice to doctors and patients who choose to sidestep the FDA: Proceed with care, and don’t count on a miracle.

The above editorial appears on Bloomberg Opinion.

Talk to us

> Give us your news tips.

> Send us a letter to the editor.

> More Herald contact information.

More in Opinion

A rendering of possible configuration for a new multi-purpose stadium in downtown Everett. (DLR Group)
Editorial: Latest ballpark figures drive hope for new stadium

A lower estimate for the project should help persuade city officials to move ahead with plans.

toon
Editorial cartoons for Thursday, June 5

A sketchy look at the news of the day.… Continue reading

Comment: Republicans’ tax bill is generational theft

The focus has been on cuts to Medicaid and SNAP, but even greater harm awaits those yet to be born.

More support needed to keep care programs running

I just don’t understand the closing of an adult day health center… Continue reading

How are cuts by Trump and RFK Jr. making us healthy?

Once I recovered from the shock of a second Donald Trump term,… Continue reading

Welch’s criticism of Democrats unpersuasive

Todd Welch’s May 28 Herald commentary criticizing Gov. Bob Ferguson’s signing of… Continue reading

Comment: MAHA report’s faked research just start of problems

RFK Jr. has the notion of research backward, forcing it to fit the conspiracies he’s always believed.

A rendering of the new vessels to be built for Washington State Ferries. (Washington State Ferries)
Editorial: Local shipyard should get shot to build state ferries

If allowed to build at least two ferries, Nichols Brothers can show the value building here offers.

Solar panels are visible along the rooftop of the Crisp family home on Monday, Nov. 14, 2022 in Everett, Washington. (Olivia Vanni / The Herald)
Editorial: ‘Big, beautiful bill’ would take from our climate, too

Along with cuts to the social safety net, the bill robs investments in the clean energy economy.

A Lakewood Middle School eighth-grader (right) consults with Herald Opinion Editor Jon Bauer about the opinion essay he was writing for a class assignment. (Kristina Courtnage Bowman / Lakewood School District)
Youth Forum: Just what are those kids thinking?

A sample of opinion essays written by Lakewood Middle School eighth-graders as a class assignment.

toon
Editorial cartoons for Wednesday, June 4

A sketchy look at the news of the day.… Continue reading

Burke: A parade for Army? Sure; but let a sibling march, too

The U.S. Merchant Marine has supplied the country’s fighting forces since the Revolutionary War.

Support local journalism

If you value local news, make a gift now to support the trusted journalism you get in The Daily Herald. Donations processed in this system are not tax deductible.