Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry

Hogan Lovells
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State-level right-to-try laws have given patients and their families hope that they might gain access to breakthrough investigational treatments. But traditionally, the FDA and pharmaceutical industry have been cautious about providing access to these treatments, at least without robust clinical study data providing preliminary evidence that the unapproved drug is effective.

As states have continued passing new right-to-try laws, it has helped make the case for expanding access at the federal level. Rob See more +

State-level right-to-try laws have given patients and their families hope that they might gain access to breakthrough investigational treatments. But traditionally, the FDA and pharmaceutical industry have been cautious about providing access to these treatments, at least without robust clinical study data providing preliminary evidence that the unapproved drug is effective.

As states have continued passing new right-to-try laws, it has helped make the case for expanding access at the federal level. Rob Church, partner in Hogan Lovells’ Pharmaceutical and Biotechnology Practice Group, discusses the opportunities – and challenges – these regulatory changes might bring. See less -

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