Jan. 29ANNAPOLIS A Frederick County delegate is pursuing legislation this year that would expand access by terminally ill patients to experimental and potentially lifesaving drugs.
Delegate Karen Lewis Young's Right to Try Act would allow access to medications that have passed the Food and Drug Administration's most basic level of clinical trials but which are not yet available to the general public.
Access would be limited to cases where a treating physician certifies that a patient has exhausted all other available treatment options.
The bill was considered at a hearing of the House Health and Government Operations Committee on Thursday.
Certain patients are able to get that access now through the FDA's so-called "compassionate use" provisions, but the process is cumbersome, said Lewis Young, D-District 3A.
Twenty-four states have passed right-to-try laws, and more than a dozen others are considering similar legislation, said Kurt Altman, an attorney with the Arizona-based Goldwater Institute, a conservative and libertarian think tank.
"What right-to-try does is allow terminally ill patients, with the recommendation of their doctor, to access investigational new drugs that their doctor believes is their best and really last hope to address their disease," Altman said.
He said patients are protected by limiting access to medications that have passed Phase 1 of the FDA approval process and are continuing through trials. If a drug is in a Phase 2 or Phase 3 trial, it means that a pharmaceutical company believes the medication is promising, he said.
Right-to-try measures have faced criticism in states where the laws have been debated.
The Pharmaceutical Research and Manufacturers of America has said such bills may be well-intentioned, but it is not in the best interest of public health to bypass FDA oversight.
On Thursday, the House committee received written testimony from Maryland health systems, including Johns Hopkins, MedStar Health, the University of Maryland Medical Center and the University of Maryland, which outlined three areas of concern, including a conflict with federal law and insurance regulations, and the possibility that early access to drugs without proven outcomes could cause patients to lose access to palliative programs such as hospice care.
However, Steve Wise, from MedChi, The Maryland State Medical Society, thanked Lewis Young for the bill and said the organization is working with lawmakers to improve the legislation, including making sure that legal protections for doctors are clear.
Two doctors also spoke in support of the bill.
"There is no public health threat from cancer patients who are trying desperately to live," Dr. David Fishkin said.
Ted Harada, a patient advocate from Georgia who was diagnosed with ALS, countered the critics who say right-to-try could expose patients to unnecessary risks.
"Well, first of all, I'm dying. I think that's a risk," he said.
A bill cross-filed by Sen. Bryan Simonaire, R-Anne Arundel, was also discussed Thursday in the Senate Finance Committee.
(c)2016 The Frederick News-Post (Frederick, Md.)
Visit The Frederick News-Post (Frederick, Md.) at www.fredericknewspost.com
Distributed by Tribune Content Agency, LLC.