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Rapid Rise of Right to Try Laws Raise Compliance and Liability Concerns

By on July 20, 2015 in Uncategorized with 0 Comments

Since 2014, over one-third of states have enacted legislation, commonly known as “Right to Try” laws, in an effort to increase access to drugs which have yet to be approved by the Food and Drug Administration, for use by the terminally ill who have exhausted their treatment options.  Under the traditional FDA regulatory scheme, drugs are subject to pre-market testing, and clinical trials were normally the only way patients could obtain access to drugs before FDA approval.  Given the lengthy FDA timelines for approving drugs and the significant difficulty patients had in obtaining drugs prior to approval, more than a dozen states have enacted their own, state-level legislation, in an attempt to expand access to drugs which have yet to received their  FDA approval.

The so-called “Right to Try” legislation enacted by 18 states share several important provisions. Generally, eligibility under these statutes require that the patient a) have a diagnosed terminal illness, b) have considered all existing treatment options approved by the FDA, yet determined that the risk from the unapproved drug is not greater than the risk from the disease, c) obtain a prescription from his/her physician, and d) provide informed consent.  Additionally, the statutes permit, but do not mandate, that drug manufacturers make the unapproved drugs available, and allow, but do not mandate, health insurers to cover the same.  Further, the statutes significantly limit the civil liability, or medical board disciplinary action, of a physician, based solely on his/her prescription of the unapproved drug.

Notwithstanding individual states’ enactment of Right to Try legislation, their effects remain uncertain, as neither manufacturers nor insurers are required to provide or insure, respectively, products which have not received FDA approval.  More importantly, federal statutes and regulations limiting the use of unapproved drugs are still likely to preempt states Right to Try laws, raising issues of liability under federal law for both manufacturers and providers.

To date, neither Pennsylvania nor New Jersey have enacted Right to Try laws, however, such laws are pending in both legislatures.[1]  In light of the rapid passage in many states, and introduction of bills in almost all states, of Right to Try laws, and the dearth of precedent for such expansive state legislation, drug manufacturers who make non FDA-approved drugs available to patients, and the physicians who prescribe these drugs under Right to Try laws must remain cautious as it remains yet to be seen how Right to Try laws will affect manufacturers’ and providers’ federal and state liability.


[1] An Act providing for the use of investigational drugs, biological products and devices by terminally ill patients, Pennsylvania House Bill 1104, available at http://www.legis.state.pa.us/cfdocs/billInfo/BillInfo.cfm?syear=2015&sind=0&body=H&type=B&bn=1104 (Introduced and referred to Health committee as of May 2015); “Right to Try Act” permitting terminally ill patients to access investigational drugs and treatment. Health, Human Services and Senior Citizens, New Jersey S.2186 / A.3474, available at http://www.njleg.state.nj.us/2014/Bills/A3500/3474_I1.PDF (referred to Assembly/Senate Health and Senior Services Committees as of June 2014).

 

Questions regarding this article may be sent to Publications@Capehart.com. 

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