Posts Tagged: Investigational Drugs

Federal “Right to Try”: Don’t Disregard Your State Laws Just Yet!

How Federal Preemption (or Lack Thereof) Could Influence the Use of Federal “Right to Try”

As discussed in our Alert of June 4, “Right to Try” Comes to the Federal Stage: What Stakeholders Should Do Now, manufacturers, patients, providers and IRBs are now grappling with two alternative federal pathways through which manufacturers may (but are not required) to provide investigational drugs for treatment purposes outside of an FDA-overseen clinical investigation. As manufacturers, treating physicians, institutions, and other stakeholders pause to consider whether to accommodate or facilitate access through the federal “right to try” law, we explore some of the factors that may influence this decision. In particular, this Alert examines the continuing force of the forty (40) enacted state “right to try” laws in relation to the new federal “right to try” law. Ironically, manufacturers seeking to avoid patchwork regulation may conclude that federal “right to try” could increase, rather than decrease, the number of requirements they need to address when voluntarily providing access. (more…)

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“Right to Try” Comes to the Federal Stage: What Stakeholders Should Do Now

On May 30, 2018, surrounded by patients directly impacted by tragic and intractable diseases, President Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (S. 204), which had passed the Senate on August 3, 2017 and then the House of Representatives on May 22, 2018 (following an unsuccessful attempt by the House to get an alternative bill, H.R. 5247, passed by the Senate this spring). The enacted federal “right to try” law follows the passage in 40 states thus far of similar state laws, a process put into motion by the Goldwater Institute, a libertarian organization in Arizona that developed the model “right to try” legislation on which most of the state laws are based.

On its face – and in the associated rhetoric – the federal “right to try” law provides a pathway through which patients may seek access to certain investigational drugs without FDA approval and also without IRB oversight. Proponents have argued that removing these oversight barriers will improve the speed with which seriously ill patients can access investigational products, while opponents have criticized “right to try” laws as offering patients false hope and increasing risks to patients. The impact of the federal law on stakeholders’ behavior remains to be seen. (more…)

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