Amy K. Dow, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Chicago office, was quoted in Managed Healthcare Executive, in “Right to Try Pros and Cons,” by Mari Edlin.

Following is an excerpt:

Some patients with life-threatening diseases will now be able to receive experimental treatments without receiving approval for their use from the FDA first.

That’s because President Trump, on May 30, signed the Right-to-Try Act into law. The signing came shortly after the House passed the legislation May 22. The Senate passed the legislation in August 2017. …

Amy K. Dow, member of law firm Epstein Becker Green… “Proponents of Right-to-Try legislation seem to overlook the fact that the FDA is not, in general, a significant barrier to access to products. Rather, it approves the vast majority of expanded access requests it receives,” says Dow.

The efforts by supporters of Right-to-Try legislation to remove FDA from the process of providing patients with access to investigational therapies eliminates an important element of oversight provided by the agency but is unlikely to significantly impact the number of patients obtaining access to these products, she adds.

She says limitations on supplies of investigational products and burdens imposed on manufacturers in responding to drug requests are not addressed by the legislation.


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