Gail Javitt Discusses Implications of “Right to Try” BillMultiple Publications May 30, 2018
Gail H. Javitt, Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in multiple publications on the topic of “Right to Try,” new legislation passed aimed at helping terminally ill patients.
Following is an excerpt from Krem-TV, “What the Right to Try Bill Means for Terminally Ill Patients,” by Rose Beltz:
Many people spend years searching for a potential cure, or struggle to get accepted into a clinical trial. On Wednesday, President Donald Trump signed the Right to Try bill into law.
This measure will give patients with potentially terminal diseases access to experimental treatments. Imagine being diagnosed with a terminal and debilitating illness. Now, imagine a possible cure or new treatment exists but you cannot get the drug that could save your life.
According to RightToTry.org, while millions of Americans are diagnosed and die, compassionate use exceptions are only granted to about 1,200 patients each year.
The Right To Try law allows Americans, who have a terminal disease who have exhausted all FDA approved medical options, to request access and try experimental medicines that have passed phase one of the FDA drug approval process. These drugs are proven to be relatively safe for humans stay in clinical trials for more evaluations but are not yet available on pharmacy shelves. …
However, ethical and political questions exist behind the law. Some policy analysts argue the legislation will not accomplish much for patients. They say it could actually make it harder to prove drugs are effective and get them approved in the future. They also fear the law will roll back the power of the FDA, loosening more than half of a decade’s worth of drug regulation.
“A drug that has only passed phase one is a drug we know very little about, and there is a very small likelihood that it will work and in fact it may do more harm than good,” Attorney Gail Javitt, who specializes in FDA Law, said.