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Right-to-Try Legislation Would Require More FDA Regulation, Which is Something Pro-Trump Forces May Not Like

Right-to-Try Legislation Would Require More FDA Regulation, Which is Something Pro-Trump Forces May Not Like | Pharma Industry Regulation |

A bipartisan bill aimed at helping terminally ill patients gain access to experimental medicines would leave intact the controversial role of the Food and Drug Administration, a notion that will likely upset backers of the so-called right-to-try movement.


“Basically, this is being designed to make the existing program easier to accomplish and encourage more companies to provide experimental medicines and larger safety studies,” explained one source familiar with the effort, who stressed the continued political jockeying may alter the language and, possibly, the intent of the bill.


Under current law, terminally ill patients who are not eligible to obtain an experimental therapy through a clinical trial can apply to the FDA for “compassionate use,” or expanded access. Think of it as a Hail Mary option. The agency approves the vast majority of such requests — over 99 percent, in fact. But critics complain the federal program is arbitrary and cumbersome, and they want to cut the FDA out of the process of approving applications, even though the agency has tried to overhaul its application process and drug makers have the final say on participation.


A nationwide campaign, backed by a libertarian think tank, has passed laws in 38 states and has sought a federal law to achieve this goal. A bill passed the Senate last August, but it stalled in the House. However, the effort is regaining steam after President Trump endorsed the idea in his recent State of the Union address and a public boost from Vice President Mike Pence (read “VP Pence is “Peddling False Hopes” to Dying Patients”;


The proposal would require the FDA to issue a guidance that would inform drug makers of their role and responsibilities, should they agree to make an experimental medicine available to a patient who is not enrolled in one of their clinical trials. Drug makers are not required to provide medicines and worry that side effects may nix their chances of winning regulatory approval.


This has been a bugaboo for the pharmaceutical industry. Beyond an unexpected adverse reaction in a patient, a company may lack sufficient supplies to grant a large number of requests. On the other hand, the proposal also stipulates that clinical outcomes concerning safety and effectiveness would also be reviewed, and the information could actually support a marketing application.


For their part, drug makers would have to submit annual reports containing various data to the FDA, such as how much medicine was supplied to a patient, how the treatment was used, and any information about side effects. The FDA, in turn, would post these reports on its website, so the information would be publicly available.

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