Posts by: Academic and Clinical Research Group

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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A Wrinkle in Common Rule Time

In an 11th hour—but nonetheless anticipated—move, the sixteen federal departments and agencies responsible for the Common Rule Final Rule that was slated to become effective tomorrow, January 19, 2018 (“Revised Common Rule”), have issued an Interim Final Rule (“IFR ”) delaying the effective date and the general compliance date of the Revised Common Rule for six months, until July 19, 2018. The IFR does not alter the compliance date for the Revised Common Rule’s provision on cooperative research (including its single IRB mandate); that date remains January 20, 2020.

The announcement provides a respite to those in the regulated community who have been working towards bringing their policies and procedures into compliance by January 19, 2018, despite the lack of any written guidance from the Office for Human Research Protections or others in the federal government regarding aspects of the Revised Common Rule that are ambiguous or otherwise challenging to implement. (more…)

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NIH Updates Policy for Issuing Certificates of Confidentiality

On September 7, 2017, the National Institutes of Health (“NIH”) released a Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality (NOT-OD-17-109) (“the Policy”). This Policy flows from the Cures Act’s changes to when and how a Certificate of Confidentiality (“Certificate”) is issued, see Pub. Law 114-255, Section 2012 (December 13, 2016), and applies to research “in which identifiable, sensitive information is collected.” The Policy goes into effect on October 1, 2017, with retroactive implications; all NIH-funded research that was “commenced or ongoing on or after December 13, 2016” will be deemed to have been issued a Certificate pursuant to the Policy. NIH has indicated that guidance on the Policy is imminent; when issued, it will likely appear on the NIH’s Certificates of Confidentiality (CoC) Kiosk.

We have identified the following preliminary questions and concerns with the Policy and will be monitoring the forthcoming guidance to see whether and how it addresses them. Institutions also may want to assess the guidance against these concerns to formulate further questions to NIH to the extent troubling aspects of the Policy remain unclear. (more…)

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The 2018 Common Rule: Implementation Checklist

As many of you know, most of the provisions of the Final Rule updating the Common Rule (“2018 Common Rule”) will go into effect, and compliance is required, on January 19, 2018. Notwithstanding some uncertainty with respect to the current Administration’s regulatory plans, as of now institutions should be taking stock of what needs to be done to bring IRBs and human research protection programs into timely compliance with the revised regulations. (more…)

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Early Adoption Not an Option for Research Rule Changes

Portions of Kate Gallin Heffernan’s presentation at the American Health Lawyers Association conference on legal issues affecting academic medical centers and teaching institutions were quoted in a March 15, 2017 Bloomberg Law: Medical Research Law & Policy Report article entitled “Early Adoption Not an Option For Research Rule Changes.” Kate and her co-presenter, Laura Odwazny, commented on recent changes to human subject protection regulations known as the Common Rule published on January 19, 2017. The full article from Bloomberg Law is linked below.

Reproduced with permission from Medical Research Law & Policy Report, 16 MRLR 06, 03/15/2017. Copyright 2017 by The Bureau of National Affairs, Inc. (800-372-1033) <http://www.bna.com/>

Download PDF of “Early Adoption Not an Option for Research Rule Changes” from Bloomberg Law.

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