<p>House lawmakers on Saturday introduced &ldquo;right to try&rdquo; legislation that would allow terminally ill patients to experiment with drugs that haven&rsquo;t been approved by the FDA.</p>
<p>&#8220;Right to try&#8221; is a priority for President Trump, who in January urged Congress to pass legislation on it during his State of the Union address. ;</p>
<p>&ldquo;We&hellip;believe that patients with terminal conditions should have access to experimental treatments that could potentially save their lives,&rdquo; said Trump. &ldquo;People who are terminally ill should not have to go from country to country to seek a cure &#8211; I want to give them a chance right here at home.&rdquo;</p>
<p>Members of the House Energy and Commerce Committee have been making changes to the Senate version of the bill, which passed unanimously in August.</p>
<p>One of the key supporters of the House bill is the Goldwater Institute, a Koch-backed libertarian public policy think tank that has helped establish &#8220;right to try laws&#8221; in 38 states. ;<em>The Right to Try Act</em> ;will &ldquo;provide millions of terminally ill Americans an additional pathway to access promising investigational treatments before it&rsquo;s too late,&#8221; said the organization. ;</p>
<p><strong>&#8220;Right to try&rdquo; is critically important for two reasons:</strong></p>
<ul>
<li>Primarily, it allows people who are dying to try experimental treatment (which they should have a right to do anyway)</li>
<li>Second, it will reduce the number of sick people who travel overseas looking for experimental treatments</li>
</ul>
<p>What makes &ldquo;right to try&rdquo; legislation controversial is how you decide which patients are sick enough to qualify. If the definition is too broad, you risk exposing a large number of patients to potentially dangerous drugs. If the definition is too narrow, you aren&rsquo;t really making a difference. ; ;</p>
<p>The House bill proposes ;&ldquo;right to try&rdquo; for patients who are likely to die &ldquo;within a matter of months&rdquo; or have a disease or condition that &ldquo;would result in significant irreversible morbidity that is likely to lead to severely premature death.&rdquo; To be eligible, patients must also have exhausted all other approved treatments. ;</p>
<p>Those who qualify will have access to drugs that have passed Stage 1 of clinical trials. The bill also requires doctors to report adverse effects and allows drugmakers to decline requests for unapproved drugs.</p>
<p>&ldquo;Following its passage, I look forward to swift Senate action so more Americans facing dire circumstances can find some light in their darkest moments,&rdquo; said House Majority Leader Kevin McCarthy (R-CA).</p>
<p>The House is expected to pass the bill Tuesday.</p>
<p><strong>The Opposition</strong></p>
<p>Critics insist &ldquo;right to try&rdquo; laws give manufacturers the opportunity to exploit patients. ;</p>
<p>&ldquo;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,&rdquo; reads a February letter signed by 38 patient advocacy groups. ;&ldquo;Clinical research subject protections are in place when experimental products are being tested to ensure the safe and ethical treatment of research participants.&rdquo;</p>
<p>Others insist &#8220;right to try&#8221; is a conservative plot to undermine the FDA. ;</p>
<p>The FDA already has a system in place that it says provides more than 99% of patients with access to unproven medications. Lawmakers say the FDA program takes too long. ;</p>
<p>The FDA&#8217;s expanded access program includes &ldquo;important ethical and safety mechanisms&rdquo; to protect patients, says American Cancer Society spokesperson Alissa Crispino. The House bill &ldquo;removes important safety protections and creates openings for potential bad actors to take advantage of patients.&rdquo; ;</p>
<p>The FDA says it has been working with lawmakers in order to &ldquo;provide technical assistance&rdquo; and &ldquo;ensure patients are also protected.&#8221;</p>