New Laws
Jan. 19, 2017
AB 1688: Patients can try drugs still in clinical trials
The bill — also known as the "Right to Try" law — was enacted last year with overwhelming bipartisan support. By Michael Headley
Michael R. Headley
Fish & Richardson PClitigation, IP law
Phone: (650) 839-5070
Fax: (650) 839-5071
Email: headley@fr.com
UC Hastings
For terminally ill patients who are desperate for a cure, Assembly Bill 1668 provides hope. The bill - also known as the "Right to Try" law - was enacted on Sept. 27, 2016, with overwhelming bipartisan support. This new legislation enables people with immediately life-threatening diseases to try investigational drugs and other medical devices that are still in clinical trials, before they are fully approved by the FDA.
Bringing a drug to market is an expensive and arduous process - studies indicate that it costs over $2.5 billion to bring a drug to market, and fewer than one of every eight drug candidates that enter clinical testing will be approved. The enormous cost and time required to develop new drugs in this regulatory environment forces patients to pay a significant price - the waiting game - while new cures await approval. For many patients suffering from life-threatening illnesses, time is the most precious resource; waiting for approval of a potentially life-saving drug can literally mean the difference between life and death.
FDA approval requires the successful completion of a three-phase clinical trial process. Phase 1 involves testing with healthy volunteers to evaluate safety; Phases 2 and 3 test new drugs on patient volunteers to evaluate effectiveness and potential side effects. It often takes ten or more years to obtain final FDA approval. AB 1668 is meant to reduce the time patients spend in limbo by making drugs available when they have successfully completed Phase 1 testing but are still undergoing Phase 2-3 testing. Specifically, AB 1668 allows (but does not require) insurers to cover the costs of investigational drugs that have passed Phase 1 clinical trials. The bill also prohibits the Medical Board from taking disciplinary action against physicians who recommend an investigational drug to patients who meet the requirements and have considered all other available treatment options.
California is not alone in passing Right to Try legislation. And while some have argued the legislation might raise preemption concerns, proponents of these laws say they implicate fundamental rights and make life better for those with few (if any) available options for treatment. At a minimum, Right to Try laws like California's have brought the issue to the forefront. If this current trend continues, California will help speed up the process and leverage the resources pharmaceutical companies spend developing new drugs to benefit patients whose lives hang in the balance.
Michael Headley is managing principal at Fish & Richardson based in Fish's Silicon Valley office. He is a trial lawyer specializing in complex disputes related to intellectual property across a broad range of technologies.
For reprint rights or to order a copy of your photo:
Email
jeremy@reprintpros.com
for prices.
Direct dial: 949-702-5390
Send a letter to the editor:
Email: letters@dailyjournal.com