PBRS 2015-Regulatory Sciences22 April 2015

Product's Safety, Efficacy, or Optimal use.Product's Safety, Efficacy, or Optimal use. Section 506B-Federal Food, Drug and Cosmetic Act .Section 506B-Federal Food, Drug and Cosmetic Act .

Post Marketing Commitments (PMCs)Post Marketing Commitments (PMCs)

Mirza Danish Hussain Barlas Assistant Manager Business Development and Regulatory Affairs

(Pharm-D , R.Ph, MBA Mkt, MBA Sc, CRCP)

Disclaimer

The information withinthis presentation is based on the

References, the Presenter's Interest andRegulatory Experience.

The FDADrug Safety and Efficacy

The Food and Drug Administration (FDA) evaluates new drug and biological products to ensure the products’ safety and efficacy for human use.

The History

In the past, FDA used the word commitment to cover both required and not required studies and clinical trials. Now, because commitments and requirements are treated differently under the law.

The Document

Post Marketing commitments (PMCs) -Are studies or clinical trials that a sponsor has agreed to conduct, but that

are not required by a statute or regulation. -Studies that FDA requires sponsors to conduct, or which sponsors agree to

conduct, after FDA has approved a product for marketing are referred to as Post Marketing study commitments (PMCs) or phase 4 commitments. 1

Characteristics of Post Marketing Commitments (PMCs)

Typically, PMCs are identified during the application review process. They do not represent major unaddressed safety and efficacy

concerns. Are intended to further refine the safety, efficacy, or optimal use of a

product, Ensure the consistency and reliability of product quality. Other Studies typically done to seek approval for new indications or

formulations, are not PMCs.

The Limitations

Commitments containing proprietary information (e.g.,

those to evaluate chemistry or manufacturing and control issues) are not included in this.

The Law Under section 506B of the Federal Food, Drug and Cosmetic Act a sponsor must

report to FDA annually on the status of the study until the study is completed or terminated.

These status reports must be submitted annually until FDA notifies the sponsor, in writing, regarding the fate of the study. Section 506B of the act also requires FDA to develop and publish in the Federal

Register annually a report on the status of Post Marketing studies that sponsors have agreed to conduct and for which they have submitted reports.

What Studies or Clinical Trials Can Be Required Today

.

Post Marketing studies or clinical trials to demonstrate clinical benefit for drugs approved under the accelerated approval requirements in 21 CFR 314.510 and 21 CFR 601.41.

Deferred pediatric studies (21 CFR 314.55(b) and 601.27(b)), where studies are required under the Pediatric Research Equity Act (PREA).

Studies or clinical trials to demonstrate safety and efficacy in humans that must be conducted at the time of use of products approved under the Animal Efficacy Rule (21 CFR 314.610(b)(1) and 601.91(b)(1)).

Studies or Clinical Trials may also be required to

.

-Assess a known serious risk related to the use of the drug.-Assess signals of serious risk related to the use of the drug.-Identify an unexpected serious risk when available data indicate the potential for a serious risk.

The References

www.accessdata.fda.gov/scripts/cder/pmcwww.accessdata.fda.gov/scripts/cder/pmc

www.fda.gov/Drugs/.../Post-marketingPhaseIVCommitments/ Independent Evaluation of FDA’s Prescription Drug User Fee Act III –

Evaluations & Initiatives Contract No. 223-04-8100 Task No. 4