BioCentury Presents: Right To Try Laws
July 2, 2014
BY STEVE USDIN, WASHINGTON EDITOR
State right-to-try laws, which have been signed by a Democratic governor in Colorado and a Republican in Louisiana, are responses to deep dissatisfaction with the pace of drug development and frustration with the ways biopharma companies have responded to pleas for early access to experimental drugs.
The two new laws, and similar bills pending in other states, are based on model legislation drafted by the libertarian Goldwater Institute. They are promoted as giving patients with life-threatening conditions and no alternatives the right to access experimental drugs early in the development process — without enrolling in clinical trials or seeking FDA approval.
However, rather than creating new rights for patients, the initiatives actually attempt to create rights for drug companies to provide experimental drugs outside the framework of FDA regulation.
The RTT laws will be effective only to the extent that the underlying assumption is correct: that FDA is the principal barrier to accessing experimental drugs. To benefit patients, the laws must also withstand possible legal challenges, and biopharma companies must be willing to rely on state law to bypass FDA oversight.
These assumptions are being put to the test now in Colorado and Louisiana, and the experiment will likely expand as a dozen or more states are likely to enact RTT laws over the next year.
It is unclear whether the state laws will deliver on their promises to patients, but coming in the wake of several high-profile compassionate access campaigns, they are certainly focusing the attention of FDA leadership, the biopharma industry, patient advocates and members of Congress on the need to improve access to experimental drugs.
Colorado House Bill 1281, which added an article to state law on access to treatments for terminally ill patients, passed both houses of the state legislature
on voice votes with no opposition. It was signed into law by Gov. John Hickenlooper, a Democrat, on May 17.
Adapting model legislation drafted by the Goldwater Institute, the Colorado law says patients with terminal illnesses “do not have the luxury of waiting until an investigational drug, biological product, or device receives final approval from the United States Food and Drug Administration.”
It adds that these patients “have a fundamental right to attempt to pursue the preservation of their own lives by accessing available investigational drugs, biological products, and devices.”
To be eligible, patients must have a terminal illness, have “considered all other treatment options currently approved” by FDA, be unable to participate in a clinical trial for the terminal illness within 100 miles of their home, or not have been accepted into a trial within one week of completing an application.
The patient must also receive a written recommendation from a physician for the investigational product.
The law applies to compounds that have “successfully completed” a Phase I trial, remain “under investigation” in an FDA-approved trial, and have not been approved for marketing.
The Colorado law frees insurers and providers of any obligation to pay for the experimental compound or treatment associated with its use.
Under the law, manufacturers are under no obligation to provide access to investigational products.
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