‘Right to try’ preserves patient freedom, puts regulators on right path
On March 21, the House of Representatives passed its “Right to Try” bill H.R. 5247 by a 267-149 margin, with 35 Democrats joining Republicans in voting for the legislation.
The bill moves to the Senate, which unanimously passed a similar bill on August 3 of last year, but where its current path into law is uncertain. The Senate should pass the House Right to Try legislation.
Designated the ‘‘Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act,” H.R. 5247 gives informed, terminally ill patients the freedom to take, and their physicians the freedom to prescribe, promising medicines that have completed initial safety testing but have not been approved by the Food and Drug Administration.
Thirty-eight states have passed Right to Try laws, but federal law supremacy probably renders these merely symbolic. A federal Right to Try law is unlikely to have much direct impact for different reasons.
First, experimental medicines are a rational choice for relatively few patients. Second, pharmaceutical manufacturers, which cannot profit from the sale of unapproved drugs, have little incentive to provide them to patients and many reasons not to do so.
Neither the Senate nor the very similar House proposal force companies to provide early access to medicines or require insurers to pay for them. This is appropriate.
Although proposed Right to Try legislation prohibits FDA from using clinical outcomes to interfere with the approval process, this protection is not absolute.
Once FDA officials are aware that untoward events have been associated with a medication, even if they ultimately prove unrelated to its use, such knowledge could consciously or unconsciously influence their review of it.
Pharmaceutical companies that provide unapproved drugs could also be subject to lawsuits by patients who claim to be injured by them. The law would eliminate many, but not all, liability suits. Consequently, Right to Try legislation is unlikely to directly impact the numbers of patients who have access to investigational therapies.
Why then will a Right to Try law be helpful? For one thing, it will highlight the seriousness of the issue among patients, physicians, drug companies and government officials. However, the most important, lasting effects of a Right to Try law will assuredly be on the FDA.