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Gail Javitt Quoted in “Three Ways ‘Right-to-Try’ Will Impact Managed Care Organizations”

Managed Healthcare Executive

Gail H. Javitt, Member of the Firm in the Health Care & Life Sciences practice, in the Washington, DC, office, was quoted in Managed Healthcare Executive, in “Three Ways ‘Right-to-Try’ Will Impact Managed Care Organizations,” by Karen Appold.

Following is an excerpt:

On May 30, President Trump signed “Right-to-Try” legislation that will allow certain drugs to be administered to terminally ill patients who have exhausted all FDA-approved treatment options and aren’t able to participate in clinical drug trials. Patients will no longer need to receive approval from the FDA to access the medications (as they did under the FDA’s Expanded Access Program). More than 1 million Americans die from a terminal illness every year. Eligible drugs must have undergone the FDA’s phase 1 of safety testing. Here’s a look at how the law could impact managed care organizations (MCOs). …

MCOs might face higher costs due to problems associated with the medications. Because drugs used under this law wouldn’t be FDA approved, their safety and effectiveness have not been completely established. …

Gail Javitt, JD, MPH, a member of Epstein Becker Green’s health care and life sciences practice, also points out that while the act prohibits a drug sponsor from paying the certifying physician, it does not restrict the certifying physician from charging the patient for the investigational therapy or for the process of obtaining it. …

The extent of the impact on MCOs is unclear because it remains to be seen how much patient access to investigational drugs will change. Forty states have already passed Right-to-Try laws. …

However, Javitt sees things differently. “The drug sponsor (typically a pharmaceutical manufacturer) will need to be willing to provide the drug,” she says. “But there isn’t any legal obligation for a drug company to do this, nor can the FDA compel a company to do so.” A company may decide not to provide an investigational drug to someone who isn’t enrolled in a clinical trial in order to ensure that sufficient quantities will be available to complete clinical investigations or for other reasons.