Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi RAPS people,

How can a company, Sponsor or investigator procure an approved drug for use in a clinical trial? Is it acceptable to simply buy an approved drug through a physician or hospital and use it in a clinical trial? Does the identity of the Sponsor matter, e.g. can this only be done through an investigator IND or can it be done with a commercial IND? Does the study design matter, e.g. would the approved drug only be allowed for subjects in the control arm of a non-inferiority trial?

Bonus question: is it possible to procure an EUA drug through the same mechanism(s) in order to use an EUA drug in a clinical trial?

Thanks!

An approved drug can be purchased for use in a clinical trial and is usually purchased through a distributor since the quantity required is more than a physician or hospital would have access to. The identity of the sponsor does not matter and the type of IND does not matter, either commercial or investigator. Most investigational studies use the approved drug as an active comparator (could be non-inferiority or superiority) or in combination with the investigational product. 

Keep in mind that if the approved drug is not used as labeled, additional requirements may apply, as it becomes an investigational use.

Taking a stab at the Bonus question: the story would be much more complicated with a EUA drug. If the EUA is for a new use of an approved drug, then yes you could purchase the approved drug in the same way, with again the caveat about whether your use is for the EUA use or the labeled use. If the EUA drug is only available for the EAU use without full marketing authorization, any clinical trial would be an investigational use and would require filing your own IND, which would require authorization by manufacturer to reference their IND.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Original Message:
Sent: 13-Dec-2021 13:58
From: Anonymous Member
Subject: Using approved drugs in clinical trials

This message was posted by a user wishing to remain anonymous

Hi RAPS people,

How can a company, Sponsor or investigator procure an approved drug for use in a clinical trial? Is it acceptable to simply buy an approved drug through a physician or hospital and use it in a clinical trial? Does the identity of the Sponsor matter, e.g. can this only be done through an investigator IND or can it be done with a commercial IND? Does the study design matter, e.g. would the approved drug only be allowed for subjects in the control arm of a non-inferiority trial?

Bonus question: is it possible to procure an EUA drug through the same mechanism(s) in order to use an EUA drug in a clinical trial?

Thanks!

Type of IND does matter! The study design also matters! a study using an approved drug (depending on changes to the drug or "as is"), in few cases you don't need an IND

------------------------------
GRSAOnline
------------------------------

Original Message:
Sent: 14-Dec-2021 07:59
From: Glen Park
Subject: Using approved drugs in clinical trials

An approved drug can be purchased for use in a clinical trial and is usually purchased through a distributor since the quantity required is more than a physician or hospital would have access to. The identity of the sponsor does not matter and the type of IND does not matter, either commercial or investigator. Most investigational studies use the approved drug as an active comparator (could be non-inferiority or superiority) or in combination with the investigational product.

Keep in mind that if the approved drug is not used as labeled, additional requirements may apply, as it becomes an investigational use.

Taking a stab at the Bonus question: the story would be much more complicated with a EUA drug. If the EUA is for a new use of an approved drug, then yes you could purchase the approved drug in the same way, with again the caveat about whether your use is for the EUA use or the labeled use. If the EUA drug is only available for the EAU use without full marketing authorization, any clinical trial would be an investigational use and would require filing your own IND, which would require authorization by manufacturer to reference their IND.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 13-Dec-2021 13:58
From: Anonymous Member
Subject: Using approved drugs in clinical trials

This message was posted by a user wishing to remain anonymous

Hi RAPS people,

How can a company, Sponsor or investigator procure an approved drug for use in a clinical trial? Is it acceptable to simply buy an approved drug through a physician or hospital and use it in a clinical trial? Does the identity of the Sponsor matter, e.g. can this only be done through an investigator IND or can it be done with a commercial IND? Does the study design matter, e.g. would the approved drug only be allowed for subjects in the control arm of a non-inferiority trial?

Bonus question: is it possible to procure an EUA drug through the same mechanism(s) in order to use an EUA drug in a clinical trial?

Thanks!

This message was posted by a user wishing to remain anonymous

A question regarding part 1 of this discussion:  if the comparator drug is approved in both EU and US, but the company wants to use the EU supply for US sites (due to cost savings), is this acceptable/legal?  I cannot find anything in the US regs describing this scenario.
Original Message:
Sent: 14-Dec-2021 07:59
From: Glen Park
Subject: Using approved drugs in clinical trials

An approved drug can be purchased for use in a clinical trial and is usually purchased through a distributor since the quantity required is more than a physician or hospital would have access to. The identity of the sponsor does not matter and the type of IND does not matter, either commercial or investigator. Most investigational studies use the approved drug as an active comparator (could be non-inferiority or superiority) or in combination with the investigational product.

Keep in mind that if the approved drug is not used as labeled, additional requirements may apply, as it becomes an investigational use.

Taking a stab at the Bonus question: the story would be much more complicated with a EUA drug. If the EUA is for a new use of an approved drug, then yes you could purchase the approved drug in the same way, with again the caveat about whether your use is for the EUA use or the labeled use. If the EUA drug is only available for the EAU use without full marketing authorization, any clinical trial would be an investigational use and would require filing your own IND, which would require authorization by manufacturer to reference their IND.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 13-Dec-2021 13:58
From: Anonymous Member
Subject: Using approved drugs in clinical trials

This message was posted by a user wishing to remain anonymous

Hi RAPS people,

How can a company, Sponsor or investigator procure an approved drug for use in a clinical trial? Is it acceptable to simply buy an approved drug through a physician or hospital and use it in a clinical trial? Does the identity of the Sponsor matter, e.g. can this only be done through an investigator IND or can it be done with a commercial IND? Does the study design matter, e.g. would the approved drug only be allowed for subjects in the control arm of a non-inferiority trial?

Bonus question: is it possible to procure an EUA drug through the same mechanism(s) in order to use an EUA drug in a clinical trial?

Thanks!

If the drug is manufactured by the same company and location it is perfectly acceptable.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Original Message:
Sent: 08-Apr-2022 09:19
From: Anonymous Member
Subject: Using approved drugs in clinical trials

This message was posted by a user wishing to remain anonymous

A question regarding part 1 of this discussion:  if the comparator drug is approved in both EU and US, but the company wants to use the EU supply for US sites (due to cost savings), is this acceptable/legal?  I cannot find anything in the US regs describing this scenario.
Original Message:
Sent: 14-Dec-2021 07:59
From: Glen Park
Subject: Using approved drugs in clinical trials

An approved drug can be purchased for use in a clinical trial and is usually purchased through a distributor since the quantity required is more than a physician or hospital would have access to. The identity of the sponsor does not matter and the type of IND does not matter, either commercial or investigator. Most investigational studies use the approved drug as an active comparator (could be non-inferiority or superiority) or in combination with the investigational product.

Keep in mind that if the approved drug is not used as labeled, additional requirements may apply, as it becomes an investigational use.

Taking a stab at the Bonus question: the story would be much more complicated with a EUA drug. If the EUA is for a new use of an approved drug, then yes you could purchase the approved drug in the same way, with again the caveat about whether your use is for the EUA use or the labeled use. If the EUA drug is only available for the EAU use without full marketing authorization, any clinical trial would be an investigational use and would require filing your own IND, which would require authorization by manufacturer to reference their IND.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 13-Dec-2021 13:58
From: Anonymous Member
Subject: Using approved drugs in clinical trials

This message was posted by a user wishing to remain anonymous

Hi RAPS people,

How can a company, Sponsor or investigator procure an approved drug for use in a clinical trial? Is it acceptable to simply buy an approved drug through a physician or hospital and use it in a clinical trial? Does the identity of the Sponsor matter, e.g. can this only be done through an investigator IND or can it be done with a commercial IND? Does the study design matter, e.g. would the approved drug only be allowed for subjects in the control arm of a non-inferiority trial?

Bonus question: is it possible to procure an EUA drug through the same mechanism(s) in order to use an EUA drug in a clinical trial?

Thanks!

I just responded to this same question; not sure if it was by you or not since you're posting anonymously. I'm not going to repeat my response, but in a nutshell, it is acceptable but they will not just assume that it is identical to the US-approved drug and you will have to provide CMC information to support its use in your IND. There are also potential limitations to how you will be able to use the clinical data in your application. See my other response for more details.

------------------------------
Rachel Thornton
Associate Director
Smyrna GA
United States
------------------------------

Original Message:
Sent: 08-Apr-2022 09:19
From: Anonymous Member
Subject: Using approved drugs in clinical trials

This message was posted by a user wishing to remain anonymous

A question regarding part 1 of this discussion:  if the comparator drug is approved in both EU and US, but the company wants to use the EU supply for US sites (due to cost savings), is this acceptable/legal?  I cannot find anything in the US regs describing this scenario.
Original Message:
Sent: 14-Dec-2021 07:59
From: Glen Park
Subject: Using approved drugs in clinical trials

An approved drug can be purchased for use in a clinical trial and is usually purchased through a distributor since the quantity required is more than a physician or hospital would have access to. The identity of the sponsor does not matter and the type of IND does not matter, either commercial or investigator. Most investigational studies use the approved drug as an active comparator (could be non-inferiority or superiority) or in combination with the investigational product.

Keep in mind that if the approved drug is not used as labeled, additional requirements may apply, as it becomes an investigational use.

Taking a stab at the Bonus question: the story would be much more complicated with a EUA drug. If the EUA is for a new use of an approved drug, then yes you could purchase the approved drug in the same way, with again the caveat about whether your use is for the EUA use or the labeled use. If the EUA drug is only available for the EAU use without full marketing authorization, any clinical trial would be an investigational use and would require filing your own IND, which would require authorization by manufacturer to reference their IND.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 13-Dec-2021 13:58
From: Anonymous Member
Subject: Using approved drugs in clinical trials

This message was posted by a user wishing to remain anonymous

Hi RAPS people,

How can a company, Sponsor or investigator procure an approved drug for use in a clinical trial? Is it acceptable to simply buy an approved drug through a physician or hospital and use it in a clinical trial? Does the identity of the Sponsor matter, e.g. can this only be done through an investigator IND or can it be done with a commercial IND? Does the study design matter, e.g. would the approved drug only be allowed for subjects in the control arm of a non-inferiority trial?

Bonus question: is it possible to procure an EUA drug through the same mechanism(s) in order to use an EUA drug in a clinical trial?

Thanks!

Hi,

Agree with Glen's answer on part 1, and part 2 is an interesting question. I re-read the EUA guidance and found the following passage that seems informative for this scenario:

"Any study or future use of an EUA product beyond the term of a [EUA] declaration is subject to investigational product regulations (e.g., IND regulations)."

I would take this to mean that the EUA drug could be purchased for use in a clinical trial, however there may be a time delimitation in the sense that the trial would need to be completed before the EUA (presumably for the comparator?) was terminated or revoked, at which point the EUA drug would revert to investigational product status. I can't say whether I agree or disagree with Glen on the need to reference the manufacturer's IND for the EUA drug, since the emergency designation mechanism may also require that information on the safety and efficacy of the EUA drug becomes 'publicly' available rather than through an exclusive right of reference. That is a very unique consideration. 

I'm curious to see what others have to say on this.

------------------------------
Marshall Hoke
Director of Regulatory Affairs
Lafayette CO
United States
------------------------------

Original Message:
Sent: 13-Dec-2021 13:58
From: Anonymous Member
Subject: Using approved drugs in clinical trials

This message was posted by a user wishing to remain anonymous

Hi RAPS people,

How can a company, Sponsor or investigator procure an approved drug for use in a clinical trial? Is it acceptable to simply buy an approved drug through a physician or hospital and use it in a clinical trial? Does the identity of the Sponsor matter, e.g. can this only be done through an investigator IND or can it be done with a commercial IND? Does the study design matter, e.g. would the approved drug only be allowed for subjects in the control arm of a non-inferiority trial?

Bonus question: is it possible to procure an EUA drug through the same mechanism(s) in order to use an EUA drug in a clinical trial?

Thanks!

Hi,

Other members have already provided answers but I just want to add my experience. 

Regarding products under EUAs, I reached out to the FDA related to clinical uses.  In that case, the intended uses of products were not authorized under their EUAs.  The FDA suggested submitting expanded access INDs with the manufacturers' LOAs.   As Marshall mentioned, EUA products are essentially investigational products.  The manufacturers may not agree to provide LOAs (especially if the intended use is not their interest or current focus).

------------------------------
Ji-Eun Kim RAC, RPH, PhD
Director, Regulatory Affairs
Scarsdale NY
------------------------------

Original Message:
Sent: 13-Dec-2021 13:58
From: Anonymous Member
Subject: Using approved drugs in clinical trials

This message was posted by a user wishing to remain anonymous

Hi RAPS people,

How can a company, Sponsor or investigator procure an approved drug for use in a clinical trial? Is it acceptable to simply buy an approved drug through a physician or hospital and use it in a clinical trial? Does the identity of the Sponsor matter, e.g. can this only be done through an investigator IND or can it be done with a commercial IND? Does the study design matter, e.g. would the approved drug only be allowed for subjects in the control arm of a non-inferiority trial?

Bonus question: is it possible to procure an EUA drug through the same mechanism(s) in order to use an EUA drug in a clinical trial?

Thanks!