Amy K. Dow, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Chicago office, was quoted in Wolters Kluwer Health Law Daily, in “Congress Gives Patients the ‘Right to Try’ Experimental Drugs, Bill Heads to White House,” by Harold Bishop.
Following is an excerpt:
Congress has passed “Right to Try” legislation that will require the federal government to allow unrestricted manufacturing, distribution, prescribing, and dispensing of experimental drugs and biologics that are intended to treat a patient who has been diagnosed with a terminal illness. The legislation does not require manufacturers to provide experimental products to patients who request them.
The House passed the legislation, known as the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (S. 204), by a vote of 250 to 169. Twenty-two Democrats voted for the bill, joining 228 Republicans. The bill was unanimously passed by the Senate on August 3, 2018. On March 3, 2018, the House passed its own version of Right to Try (H.R. 5247), but it lost traction in the Senate. The White House requested action so the House decided to take up the previously passed Senate version. …
Amy Dow, a member in the Chicago law office of Epstein Becker & Green, P.C., has stated that while S. 204 would address some of the challenges that limit patients’ access to investigational products, it is not “a panacea.”
According to Dow, “many of the more significant barriers to increasing access to investigational products cannot be adequately addressed by Right to Try legislation, as these bills do not obligate manufacturers to make investigational products available to patients or allocate funding to address the substantial costs associated with requests for access by individuals.” As a result, Dow believes that “S. 204 is not likely to overcome challenges resulting from manufacturers’ often limited supplies of investigational products and the burdens imposed on manufacturers and their personnel, who may be operating with limited resources, to fulfill requests from patients for access to investigational products.” She is also concerned that “S. 204 also does nothing to overcome ethical concerns regarding the diversion of resources, in the form of product, personnel and funds, from efforts to make a product available to all patients who could benefit from it to an individual patient.”
Dow concludes “while the added protections from liability and regulatory burdens provided by S. 204 may be sufficient to convince some manufacturers to approve a greater number of requests for access to investigational products, I anticipate that many, particularly smaller manufacturers, will continue to limit approval of these requests.”