- September 04, 2018
If passed, the bill would have enabled terminally ill patients to access unapproved drugs if a doctor and the manufacturer of the medicine agreed. Today, patients must get the clearance of a doctor, the manufacturer and the FDA. The rejected legislation would have stripped the FDA of the power to stop patients accessing medicines and limited its role to the receipt of safety reports.
Given the FDA approves almost all requests to access unapproved medicines, it is questionable how big an effect the law would have on the treatment options of terminally ill patients. However, the proposal nonetheless provoked strong reactions in the House and beyond.
Some Republicans were accompanied to the debate about the bill by patients with terminal diseases, the AP reports, or cited messages from constituents affected by the law. A patient with amyotrophic lateral sclerosis said a vote against the legislation “is essentially a vote to kill me.”
Those strong messages and the support of the White House failed to sway 138 Democrats and two Republicans. Objections to the bill were underpinned by the belief that it would have little effect on access to medicines but would render patients vulnerable to exploitation by unscrupulous doctors and drugmakers, who would have total control if the FDA was cut out of the process.
The vote means that view, which is held by many patient and research groups, has won out for now. However, House Republicans plan to return to the topic. As the Senate has already passed a similar bill, proponents of right-to-try could push legislation through under rules that would only require them to get a majority. This week’s vote suggests the bill would comfortably clear that lower bar.
REFERENCE: Fierce BioTech; 14 MAR 2018; Nick Paul Taylor