Pharmaceutical and biotechnology companies need to start preparing for the compliance and reporting requirements of a controversial new law.
US President Donald Trump on May 30 signed into law the Right to Try Act (H.R.5247), which will allow eligible patients, through drug manufacturers, to seek access to drugs that have not yet been approved by the Food and Drug Administration (FDA). In order to be eligible, a patient must be diagnosed with a disease or condition that they are likely to die from within a matter of months, or that causes significant irreversible morbidity likely to lead to a severely premature death.
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The Right to Try Act was not met with unanimous approval. Prior to its passing, the bill was stalled in the House due to concerns for patient safety. Shortly after the Right to Try Act was signed, an updated version was introduced that added additional patient protections.
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[T]he National Organization for Rare Disorders, an organization supporting more than 30 million patients with rare diseases, issued a statement to the House stating, “we have strongly opposed all Right to Try legislation, as we do not believe that it will safely and genuinely increase access to investigational therapies outside of clinical trials.”
Regardless of any lingering controversy, pharmaceutical and biotechnology companies will need to start preparing for the compliance requirements that this legislation brings.
Read full, original post: The ‘Right To Try Act’: Another Compliance Requirement For Pharma And Biotech Companies
