Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I recently heard that some states, like Michigan, have passed laws to allow the conduct of a drug/biologic human clinical study without going through FDA and opening an IND. Does anyone know if this is accurate or what the circumstances would be to do this? I assume you would need an IRB ok but I don't know. Doesn't seem right to me so I thought I would ask the regulatory community.

I've never heard of this. In theory, based on the 10th Amendment I guess it could be possible for a state to pass those kinds of laws to allow approval of drugs that will marketed only in that one state. In practice, though, it wouldn't make any sense for the state government or for the trial sponsor.

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Michael Hellerstein
GeoVax, Inc.
Smyrna GA
United States
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Original Message:
Sent: 15-Oct-2017 11:30
From: Anonymous Member
Subject: Can you bypass an IND for some clinical trials

This message was posted by a user wishing to remain anonymous

I recently heard that some states, like Michigan, have passed laws to allow the conduct of a drug/biologic human clinical study without going through FDA and opening an IND. Does anyone know if this is accurate or what the circumstances would be to do this? I assume you would need an IRB ok but I don't know. Doesn't seem right to me so I thought I would ask the regulatory community.

I think there may be some confusion and that what you are hearing about it is the Right to Try law.  These laws, passed now by quite a few states with versions also going thru the US Congress, allows patients to obtain experimental products from the manufacturer without approval from FDA.  They are not clinical trials and the data from these uses cannot be used to obtain marketing approval.  It is not much different in concept from expanded access programs where the FDA is involved.  There has been a lot of press and recent political activity related to this and FDA has been active in making expanded access easier for patients and physicians.  The bottleneck to any of these programs is that manufacturers have been very reluctant to supply medication to individual patients where there is no control over how the drug would be used and possible negative repercussions if there are bad outcomes.

https://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/default.htm

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Glen Park
Scynexis, Inc.
Jersey City NJ
United States
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Original Message:
Sent: 15-Oct-2017 11:30
From: Anonymous Member
Subject: Can you bypass an IND for some clinical trials

This message was posted by a user wishing to remain anonymous

I recently heard that some states, like Michigan, have passed laws to allow the conduct of a drug/biologic human clinical study without going through FDA and opening an IND. Does anyone know if this is accurate or what the circumstances would be to do this? I assume you would need an IRB ok but I don't know. Doesn't seem right to me so I thought I would ask the regulatory community.

​To answer the specific question, FDA laws and regulations over investigational new drugs and biologics would require submission of an IND regardless of any state law.  FDA would have jurisdiction unless the clinical study was conducted only within state lines.  This is virtually impossible since FDA could demonstrate that either the investigational drug, the container closure, package, or similar study related materials was manufactured or sourced from outside the borders of the state from which the study would be conducted.

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Michael Trapani
Senior Consultant
Biologics Consulting Group, Inc.
Monroe Township NJ
United States
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Original Message:
Sent: 15-Oct-2017 11:30
From: Anonymous Member
Subject: Can you bypass an IND for some clinical trials

This message was posted by a user wishing to remain anonymous

I recently heard that some states, like Michigan, have passed laws to allow the conduct of a drug/biologic human clinical study without going through FDA and opening an IND. Does anyone know if this is accurate or what the circumstances would be to do this? I assume you would need an IRB ok but I don't know. Doesn't seem right to me so I thought I would ask the regulatory community.

I agree with Michael regarding FDA jurisdiction. However, in some instances, FDA allows phase 1 studies to be conducted with currently marketed products.  It is necessary to meet with the Agency and discuss the proposed plan.  Usually the sponsor must stay within labeled dosing allowances.  I am not sure why a company would want to do this unless they believed the chance of going to phase 2 is very low.

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Nancy Chew RAC
President
Regulatory Affairs, North America, Inc.
Durham NC
United States
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Original Message:
Sent: 17-Oct-2017 09:40
From: Michael Trapani
Subject: Can you bypass an IND for some clinical trials

​To answer the specific question, FDA laws and regulations over investigational new drugs and biologics would require submission of an IND regardless of any state law.  FDA would have jurisdiction unless the clinical study was conducted only within state lines.  This is virtually impossible since FDA could demonstrate that either the investigational drug, the container closure, package, or similar study related materials was manufactured or sourced from outside the borders of the state from which the study would be conducted.

------------------------------
Michael Trapani
Senior Consultant
Biologics Consulting Group, Inc.
Monroe Township NJ
United States

Original Message:
Sent: 15-Oct-2017 11:30
From: Anonymous Member
Subject: Can you bypass an IND for some clinical trials

This message was posted by a user wishing to remain anonymous

I recently heard that some states, like Michigan, have passed laws to allow the conduct of a drug/biologic human clinical study without going through FDA and opening an IND. Does anyone know if this is accurate or what the circumstances would be to do this? I assume you would need an IRB ok but I don't know. Doesn't seem right to me so I thought I would ask the regulatory community.

Further to the comments from others in this discussion, I am not aware of any exceptions to the need to get an IND before conducting a clinical trial on an unapproved drug in the United States, other than those in 21 CFR 312.2(b). That is, if one wants to study an unapproved drug an IND is required -- irrespective of whether the data will be used to support an application. That is, even if the drug is a) low/"no" risk, b) cleared by an IRB, c) won't be used to support advertisiing or labeling, ... if it is truly a new drug -- there is no choice but to get an IND approval. Does anyone disagree with this? There are many research and regulatory professionals who believe that, if the study is small, or if the active ingredient has prior approval for another therapeutic indication, or if the data will not be used to support an application... an IND is not necessary.

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Jennifer R. Martin
Director - Regulatory Affairs

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Original Message:
Sent: 17-Oct-2017 12:49
From: Nancy Chew
Subject: Can you bypass an IND for some clinical trials

I agree with Michael regarding FDA jurisdiction. However, in some instances, FDA allows phase 1 studies to be conducted with currently marketed products.  It is necessary to meet with the Agency and discuss the proposed plan.  Usually the sponsor must stay within labeled dosing allowances.  I am not sure why a company would want to do this unless they believed the chance of going to phase 2 is very low.

------------------------------
Nancy Chew RAC
President
Regulatory Affairs, North America, Inc.
Durham NC
United States

Original Message:
Sent: 17-Oct-2017 09:40
From: Michael Trapani
Subject: Can you bypass an IND for some clinical trials

​To answer the specific question, FDA laws and regulations over investigational new drugs and biologics would require submission of an IND regardless of any state law.  FDA would have jurisdiction unless the clinical study was conducted only within state lines.  This is virtually impossible since FDA could demonstrate that either the investigational drug, the container closure, package, or similar study related materials was manufactured or sourced from outside the borders of the state from which the study would be conducted.

------------------------------
Michael Trapani
Senior Consultant
Biologics Consulting Group, Inc.
Monroe Township NJ
United States

Original Message:
Sent: 15-Oct-2017 11:30
From: Anonymous Member
Subject: Can you bypass an IND for some clinical trials

This message was posted by a user wishing to remain anonymous

I recently heard that some states, like Michigan, have passed laws to allow the conduct of a drug/biologic human clinical study without going through FDA and opening an IND. Does anyone know if this is accurate or what the circumstances would be to do this? I assume you would need an IRB ok but I don't know. Doesn't seem right to me so I thought I would ask the regulatory community.

Original Message------

This message was posted by a user wishing to remain anonymous

I recently heard that some states, like Michigan, have passed laws to allow the conduct of a drug/biologic human clinical study without going through FDA and opening an IND. Does anyone know if this is accurate or what the circumstances would be to do this? I assume you would need an IRB ok but I don't know. Doesn't seem right to me so I thought I would ask the regulatory community.

Although "right to try" laws have been passed in 38 states, as far as I know, none of them require physicians to prescribe experimental therapies, nor manufacturers to provide them to physicians, nor third-party payors to pay for them. 

Due to liability concerns, few physicians are expected to prescribe drugs under these laws and, for similar reasons, few manufacturers are likely to provide them without an IND. And payors aren't likely to pay for anything they don't have to pay for.

These laws seem to appeal mostly to legislators.

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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 15-Oct-2017 11:30
From: Anonymous Member
Subject: Can you bypass an IND for some clinical trials

This message was posted by a user wishing to remain anonymous

I recently heard that some states, like Michigan, have passed laws to allow the conduct of a drug/biologic human clinical study without going through FDA and opening an IND. Does anyone know if this is accurate or what the circumstances would be to do this? I assume you would need an IRB ok but I don't know. Doesn't seem right to me so I thought I would ask the regulatory community.

Federal law states that any drug that affects interstate commerce, which Michael Trapani explained is every drug, is adulterated or misbranded unless it has an NDA. An IND is one of the few exceptions to the NDA requirement. This federal law pre-empts any state laws.
It is a shame that legislators are willing to pass bad laws so that they can lie about them in their campaign ads, especially when patients, practitioners, and manufacturers, too who are confused about them are exposed to criminal liability.
FDA already has a generous program to expedite small clinical trials, even with a single patient, and waive any fees that may apply. FDA generally expects the involved clinicians to collect safety data during these uses. That is a much better option for everyone. Check out the FDA IND Toolkit here (link).

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Andrea Chamblee Esq., RAC, FRAPS

This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.

Silver Spring MD
United States
------------------------------

Original Message:
Sent: 15-Oct-2017 11:30
From: Anonymous Member
Subject: Can you bypass an IND for some clinical trials

This message was posted by a user wishing to remain anonymous

I recently heard that some states, like Michigan, have passed laws to allow the conduct of a drug/biologic human clinical study without going through FDA and opening an IND. Does anyone know if this is accurate or what the circumstances would be to do this? I assume you would need an IRB ok but I don't know. Doesn't seem right to me so I thought I would ask the regulatory community.

Yes you may bypass an IND for some clinical trials:

FDA Guidance:
Determining Whether Human Research Studies Can Be Conducted Without an IND

https://www.fda.gov/downloads/drugs/guidances/ucm229175.pdf


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Saurabh Kothari MSRA, MSBE, RPh, CCRP, RAC
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Original Message:
Sent: 23-Oct-2017 10:44
From: Andrea Chamblee
Subject: Can you bypass an IND for some clinical trials

Federal law states that any drug that affects interstate commerce, which Michael Trapani explained is every drug, is adulterated or misbranded unless it has an NDA. An IND is one of the few exceptions to the NDA requirement. This federal law pre-empts any state laws.
It is a shame that legislators are willing to pass bad laws so that they can lie about them in their campaign ads, especially when patients, practitioners, and manufacturers, too who are confused about them are exposed to criminal liability.
FDA already has a generous program to expedite small clinical trials, even with a single patient, and waive any fees that may apply. FDA generally expects the involved clinicians to collect safety data during these uses. That is a much better option for everyone. Check out the FDA IND Toolkit here (link).

------------------------------
Andrea Chamblee Esq., RAC, FRAPS

This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.

Silver Spring MD
United States

Original Message:
Sent: 15-Oct-2017 11:30
From: Anonymous Member
Subject: Can you bypass an IND for some clinical trials

This message was posted by a user wishing to remain anonymous

I recently heard that some states, like Michigan, have passed laws to allow the conduct of a drug/biologic human clinical study without going through FDA and opening an IND. Does anyone know if this is accurate or what the circumstances would be to do this? I assume you would need an IRB ok but I don't know. Doesn't seem right to me so I thought I would ask the regulatory community.