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Focus on Regulation

California Tries the “Right to Try” Act — FDA’s Expanded Access Regulations Remain in Force

On September 27, 2016, California Governor Jerry Brown signed into law the so-called “Right to Try Act” (AB-1668) (the “RTA”), which allows qualifying patients to request from manufacturers unapproved drugs, biologics, or medical devices that have successfully completed FDA-sanctioned Phase I clinical trial(s). In general terms, this law allows a manufacturer of an investigational drug, biologic, or medical device to make its investigational product available to an eligible patient notwithstanding other California laws that may prohibit such a practice. The new law also permits the manufacturer to charge the patient for the costs associated with manufacturing the product. Under the RTA, “eligible patient” generally means a person whose disease or condition creates “a reasonable likelihood that death will occur within a matter of months” and who obtains two physician attestations regarding his or her eligibility under this law.

Some commentators have asserted that the RTA allows patients to circumvent FDA’s expanded access requirements for treatment use of experimental therapies. Our preliminary assessment is that California’s RTA does not modify or prevail over the federal laws and regulations governing the distribution of investigational drugs or devices. In other words, parties that wish to provide investigational drugs to patients for treatment purposes are still subject to FDA’s expanded access regulations, which for drugs and biologics appear at 21 CFR 312 Subpart I.

With respect to the text of the RTA, a key feature is that actions taken pursuant to the law cannot serve as a basis for any civil, criminal, or disciplinary claim or cause of action under state law. Such actions might include legal claims against the manufacturer or any other person or entity involved in the care of the eligible patient for harm done to the patient or his/her heirs, except where there is a failure to exercise reasonable care.

California’s RTA has clear similarities to and differences from FDA’s expanded access regulations. Some similarities include the purpose of the programs, the requirement of obtaining a professional or clinical opinion that comparable or satisfactory treatment alternatives do not exist, and the fact that manufacturers can decide whether or not to provide their investigational product to any given requesting patient who complies with applicable laws.

One main difference between the California’s law and FDA’s expanded access program is that – in contrast to California’s relatively narrow definition of an eligible patient – FDA’s expanded access regulations have a significantly broader definition: eligible patients are those who (i) have a reasonable likelihood of death within a matter of months, (ii) are likely to be subject to a premature death without early treatment, or (iii) have a disease or condition associated with morbidity with a substantial impact on day-to-day functioning. Another difference is that the RTA only requires two physicians to recommend or approve a patient’s request—no prior review by government regulators is needed.

There is, however, some uncertainty in how the California law will interrelate with FDA’s regulatory scheme for investigational products. For example, some unresolved issues regarding California’s RTA include the following:

  • Whether FDA will exercise enforcement discretion and not try to enforce its expanded access regulations against parties in California who obtain access to investigational products under the RTA.
  • Whether manufacturers will be receptive to RTA requests for investigational products. Much like FDA’s expanded access program, manufacturers are not required to provide investigational products to eligible patients under this law.

California’s RTA is far from cutting edge however—according to recent reports, 32 states, including California, have passed Right to Try laws. Although FDA issued three guidance documents regarding its own expanded access program in June 2016, the Agency does not appear to have taken any stance on Right to Try laws passed by the various states.

If you have any questions about the Right to Try Act or would like to submit comments, please feel free to contact one of the Hogan Lovells attorneys listed above.