Right-to-Try Doesn’t Help Patients, Hurts FDA, Drugmakers

Bloomberg Law Pharma & Life Sciences

Gail H. Javitt, Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, authored an article in Bloomberg Law Pharma & Life Sciences, titled “Right-to-Try Doesn’t Help Patients, Hurts FDA, Drugmakers.”

Following is an excerpt:

On May 22, the House of Representatives passed S. 204, the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2017 (generally known as the “Right-to-Try” bill). The Senate previously passed the bill in August 2017. President Donald Trump, who had strongly advocated for the passage of the legislation, will soon sign it into law.

The Right-to-Try bill, which amends the Federal Food, Drug, and Cosmetic (FD&C) Act, removes from FDA the authority to oversee access by terminally ill patients to early stage investigational therapies. Under the new law, FDA will no longer have authority over the administration of “eligible” investigational therapies to “eligible” patients. …

The bill also sharply constrains FDA’s ability to use information about an eligible patient’s experience with an eligible investigational drug to delay or adversely affect the agency’s review of the sponsor’s NDA. Absent a request from the sponsor to use such outcome data, a senior FDA official (Center Director or above) must make a determination that use of the eligible patient’s clinical outcome information is “critical” to determining the drug’s safety and must provide written notice that includes a public health justification for the determination to the sponsor.

The bill requires manufacturers who agree to provide investigational therapy to eligible patients to report annually to FDA the number of doses supplied, the number of patients treated, the uses for which the drug was made available, and any known serious adverse events. This information will be posted on FDA’s website.

Finally, the bill also includes provisions aimed at shielding manufacturers and physicians from liability arising from their activities related to providing the drug and, conversely, from their decision not to grant a patient’s request to obtain access to an investigational product.