Question

Locate the document: “Guidance for Clinical Investigators, Sponsors, and IRBs Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND” (September 2013) and use this resource to address the following:

1a. According to this document, is a drug considered to be different from a biologic? Provide justification(s) for your response and include relevant references. (10)

The IND regulations (21 CFR 312) make it clear that FDA generally expects that clinical trials used to support a new indication for a drug/biologic will be conducted under IND.

How does the guidance provided in the guidance document referenced above compare with this expectation? Your response should make it clear that you believe that the guidance document agrees with OR contradicts 21 CFR 312 regulations on this subject depending on your position (20)

Using only information from the most recent PDUFA report (in other words, put your opinions aside for this question), make a case for OR against the following statement (20):

“The current PDUFA fee arrangement that allows FDA to use fees paid by the industry it is charged with regulating for review activities is flawed and cannot be expected to result in a scientific and fair evaluation of submissions by the pharmaceutical industry.

“ Your response should include a statement that you are arguing for OR against the statement and should include document location information (page, section….) for the evidence you cite.

Answer 1

1a. According to this document, is a drug considered to be different from a biologic? Provide justification(s) for your response and include relevant references. (10)

Yes ,according to this document the drug is different from biological product in these aspects

1. Biologic are compounds ( for eg: vaccines from dead or live attenuated viruses) which can affect the structure and function of the body. In this context “biologic ” can also be considered as drugs.
2. Drugs are substance intended for therapeutic purpose and also affect structure of function of body in any means.
3. Substance for ex: dietary supplement which also affect the metabolism (like provides proteins, vitamins etc) is not considered as a drug.

The IND regulations (21 CFR 312) make it clear that FDA generally expects that clinical trials used to support a new indication for a drug/biologic will be conducted under IND.

How does the guidance provided in the guidance document referenced above compare with this expectation? Your response should make it clear that you believe that the guidance document agrees with OR contradicts 21 CFR 312 regulations on this subject depending on your position (20)

Using only information from the most recent PDUFA report (in other words, put your opinions aside for this question), make a case for OR against the following statement (20):

I agrees with the regulations mentioned in 21CFR312 to do clinical trials using a pre FDA approved drug for a new indications.

For ex. Lets think that the drug X which is used to bring down cholesterol levels is approved by FDA and already in market. I think that this drug can also treat some thyroid function abnormalities.

I can do my clinical trails in a patient population and this trial need not be conducted under IND ,Provided I also take IRB approval and informed consent from the subjects.

“The current PDUFA fee arrangement that allows FDA to use fees paid by the industry it is charged with regulating for review activities is flawed and cannot be expected to result in a scientific and fair evaluation of submissions by the pharmaceutical industry.

“ Your response should include a statement that you are arguing for OR against the statement and should include document location information (page, section….) for the evidence you cite.

“PDUFA IV removed the three-year limitation on postapproval activities, and again expanded the list of postmarket safety activities that the fees could support. New items on the list included developing and using adverse-event datacollection systems, including information technology systems; developing and using improved analytical tools to assess potential safety problems, including access to external databases; implementing and enforcing new FFDCA requirements relating to postapproval studies, clinical trials, labeling changes, and risk evaluation and mitigation strategies; and managing adverse event reports.”(ref Prescription Drug User Fee Act (PDUFA): 2012 Reauthorization as PDUFA V, page 9)

I agree to this regulation because for a drug to market it will take minimum 15-20 years starting from drug design to clinical trails . So it will be helpful to companies if fees is low and shorten the time taken for decision from FDA. In fact a new approved compound will be equal to life for many subjects.