Editorial: There’s more to right-to-try bills than appears

Published: 3/31/2016 2:44:48 PM

Pharmaceutical companies can offer patients great hope. Recent decades have seen a parade of life-saving and life-preserving drugs, one after the other. HIV/AIDS has been turned from a death sentence into a manageable, chronic disease. Hepatitis C can now be cured for many.

So it’s no wonder that legislators in states across the country, including New Hampshire, have looked skeptically at the Food and Drug Administration. The FDA, after all, is the agency responsible for screening medicines for potential drawbacks before bringing them to doctors and patients. These legislators have introduced so-called “right to try” legislation, which is advertised as allowing patients to gain easier access to experimental drugs still in development.

The laws are something of a pet project of the Goldwater Institute, a libertarian group. They allow patients and their doctors to do an end run around the FDA, applying directly to drug companies if they feel a drug is right for them. More than two dozen states have enacted the legislation so far.

Just such a bill, HB 1138, has been introduced in New Hampshire, by Republican Frank Edelblut. It passed the House earlier this month and is now awaiting action in the Senate.

While the bill may be well-intentioned, there is no evidence so far that such legislation works as intended. The state Senate should reject the bill and wait until there are clear and convincing examples of such legislation actually expanding access to lifesaving drugs as opposed to weakening a federal regulatory body.

For one thing, there is no evidence that the bills have helped any patient obtain a single dose of any drug. Given the large number of states enacting such laws, that should give legislators pause. Pharmaceutical companies prefer to work with, rather than outside of, the FDA. The companies have historically made such drugs available through “compassionate use” or “expanded access” programs, administered through the federal agency.

And while some patients have complained about the red tape involved in these programs, the FDA has also been responsive to their concerns. Last year, it introduced a streamlined way for doctors to apply for experimental treatments to help their patients.

It’s certainly possible that the FDA is responding to the recent rash of right-to-try laws and is attempting to protect its turf. But if that’s the case, the agency should be commended rather than criticized. It is reacting to concerns of those who need experimental therapies, while also extending the protections of an agency with incredible safety resources. After all, there are reams of data involved in drug trials, which the FDA is charged with making sense of.

Ultimately, New Hampshire’s flirtation with the law seems like a solution in search of a problem. Doctors and patients should work within the existing system, and push for changes, rather than take risks outside of it.

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