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Regulatory Focus™ > News Articles > Public Citizen Warns 'Right to Try' Gives Patients False Hope

Public Citizen Warns 'Right to Try' Gives Patients False Hope

Posted 06 March 2017 | By Michael Mezher 

Public Citizen Warns 'Right to Try' Gives Patients False Hope

Advocacy nonprofit Public Citizen is calling on members of Congress to oppose several "right to try" bills, warning that the bills would undermine the US Food and Drug Administration (FDA) and provide false hope to patients.

In recent years more than 30 states have adopted right to try laws that seek to provide terminally ill patients access to unapproved drugs, with several new congressional efforts to create a federal right to try program.

The White House has signaled its support for right to try, with President Donald Trump suggesting that FDA stands in the way of terminally ill patients trying to access experimental drugs, and Vice President Mike Pence meeting with right to try advocates last month.

Now, in a letter sent to members of the House and Senate on Monday, Public Citizen warns that enacting federal right to try legislation could harm patients.

"We are concerned that false hope legislation like S. 204, H.R. 878 and H.R. 1020 would put countless patients at risk by dramatically undermining the FDA's role in ensuring that medical products are safe and effective before they become widely used," writes Public Citizen Director Michael Carome and researcher Sarah Sorscher.

The bills, they say, would expose patients to harm without affording them the safeguards provided by clinical trials or FDA's expanded access program, such as informed consent, institutional review board (IRB) review, and safety monitoring.

"Patients are also able to sue their doctor or the manufacturer for violating standards of care, including by failing to obtain fully informed consent. In addition, FDA prevents manufacturers from profiting from sale of drugs offered through the expanded access program," Sorscher told Focus.

However, Public Citizen also cautions that it's still unclear whether FDA's expanded access program has benefited patients who have accessed drugs through it.

"Many of the experimental products made available through this program ultimately are not shown to be safe and effective in clinical testing and are not approved or cleared by the FDA. Despite patients' hopes, there is no evidence that the current expanded access program helps more patients than it harms," Carome and Sorscher write.

Additionally, Sorscher told Focus that the right to try proposals before Congress do little to address one of the main barriers to providing patients unapproved drugs.

"FDA has granted 99% of the expanded access requests it receives. Generally, in cases where the patient does not gain access, it is because either his or her physician did not agree to assist, or the manufacturer did not agree to share the drug. The federal bills do nothing to compel manufacturers to provide these experimental products to patients," Sorscher said.

Public Citizen


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