http://www.curetoday.com/publications/cure/2018/spring-2018/house-approves-bill-that-would-give-critically-ill-patients-early-access-to-experimental-drugs
House Approves Bill That Would Give Critically Ill Patients Early Access to Experimental Drugs

Kristie Kahl

The House of Representatives has passed a controversial right-to-try bill that would give critically ill patients quick access to experimental drugs.

On March 21, House members voted 267 to 149 along party lines on the Republican-backed measure. The next step will be for the Senate, which sup­ports the concept and passed its own version of the legislation over the sum­mer, to consider the bill.

“We … believe that patients with terminal conditions, terminal illness, should have access to experimental treatment immediately that could potentially save their lives,” President Donald Trump said during his Jan. 30 State of the Union address.

Right-to-try legislation allows patients who are terminally ill to take experimental drugs that have met the goals set for them in phase 1 testing within the review process of the Food and Drug Administration (FDA). During that early phase of testing, drugs are considered experimental.

Right-to-try legislation is already a law in 38 states and under consider­ation in 12 more. Supporters say the bill is needed to quell patient fears that the federal government could reverse these state regulations.

Those who oppose the bill say that the use of unapproved drugs would bypass the FDA’s authority and under­mine both drug development and patient safety. They also argue that the bill would not guarantee patient access to experimental drugs, because it would not require pharmaceutical companies to provide them. Opponents also note that patients already have an effective route for gaining access to experimental drugs: the FDA’s compas­sionate-use program.

“It is important to remember that the current regulatory system for medical products and research in the United States was created as a result of seri­ous patient harm and exploitation that occurred early in the 20th century,” said Keysha Brooks-Coley, vice president of federal affairs for the American Cancer Society Cancer Action Network, the organization’s lobbying arm. “Clinical research protections are in place when experimental products are being tested to ensure the safe and ethical treat­ment of research participants.”
 
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