FDA Commissioner Robert Califf, during remarks at the Food and Drug Law Institute's annual conference earlier this month, commented on the 21st Century Cures Act passed in the House and related legislation pending in the Senate. Commissioner Califf stressed, "it is vital that the legislation accomplishes the twin goals of promoting innovation and preserving the safety and effectiveness standard" because "[i]nnovative therapies are not helpful to patients if they don't work, or worse, cause harm." He warned that the legislation, "if not carefully crafted, could pose significant risks for FDA and American patients." In addition to citing safety and efficacy concerns, Commissioner Califf noted that "it is equally important that FDA receive adequate resources for any new responsibilities in the legislation."
In January 2016, the Senate Health, Education, Labor and Pensions ("HELP") Committee announced that it would vote on individual biomedical innovation bills in a "step by step" manner. To date, the Senate HELP Committee has passed 19 bills as part of a medical innovation package. Five bills the committee passed last month include a bill to help FDA and the National Institutes of Health ("NIH") recruit top talent (S. 2700), a bill to create a new drug approval pathway for certain antibiotic drugs (S. 185), a bill to encourage the Secretary of Health and Human Services to carry out a precision medicine initiative (S. 2713), a bill to require NIH to develop and facilitate collaboration in research (S. 2745), and a bill to reduce administrative burdens on researchers at NIH (S. 2742). Commissioner Califf's remarks may foreshadow some of the concerns lawmakers will grapple with when the bills go to the Senate floor, which may be as soon as next month if senators can reach an agreement on NIH funding.
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