A growing number of states are enacting "Right to Try" laws, which attempt to bypass the FDA's new drug approval process by allowing terminally ill patients access to drugs that have successfully completed only a Phase I Clinical Trial. A major stumbling block to access, however, is the fact that states can't trump the FDA's regulatory authority over unapproved drugs, according to the U.S. Constitution. A bill recently introduced in Congress, the "Right to Try Act of 2015" (HR 3012) seeks to remove this hurdle by allowing access to unapproved drugs in states having a Right to Try law.

State right to try laws are a superficially appealing idea. What's wrong, the argument goes, with allowing terminally ill patients access to "potentially life saving" drugs? As it turns out, there's plenty wrong. David Gorski, MD, and I have written several posts over on SBM about the pitfalls of Right to Try. (Other posts by David can be found here, here, and here.) As we've pointed out, among other things:

HB 3012 removes the FDA as an impediment to what would otherwise be unauthorized access to an unapproved drug. It provides that the federal government "shall not take any action to prohibit the production, manufacture, distribution, prescribing, dispensing, possession, or use of an experimental drug, biological product, or device" as long as it is authorized by state law and the drug, product or device has successfully completed a Phase I investigation and it remains under investigation by the FDA.

It is unsurprising that two of the bills three sponsors are Arizona congressmen. Arizona is home to the Goldwater Institute, a libertarian "think tank" whose only interest in health care policy appears to be pushing these laws thorough state legislatures as a thumb in the FDA's regulatory eye and lambasting the Affordable Care Act. The Robert Wood Johnson Foundation this ain't. The Institute's misleading and factually questionable position paper, along with its Right to Try model legislation, give proponents a slickly produced PR weapon to hand out to legislators. It will fly its lobbyists in to testify before legislative committees as well.

HB 3012 not only upends the FDA's new drug application process, it is also at odds with more thoughtful legislation now before Congress to expedite the FDA's Expanded Access program, which is admittedly slow and cumbersome. (See Sec. 2082 & 2083) The FDA issued draft guidance back in 2013 to expedite the process but never finalized it. This proposed legislation is part of the comprehensive "21st Century Cures Act," a bipartisan effort that passed in the House and has a reasonable chance of passing in the Senate. By any fair estimation, the Act will render state Right to Try laws and HB 3012 unnecessary, while retaining FDA control over the drug approval process. Of course, it won't alleviate the Goldwater Institute's ideological problem with the FDA -- indeed with practically all regulatory authority. Good for patients, and too bad for them.