Drug Approval Process - An Overview

• Author: Kenneth Dorsney
• Pages: 25-31

25

chapter 2

Drug Approval Process—

An Overview1

A drug sponsor must obtain Federal Drug Administration (FDA) approval

of a new drug application (NDA) prior to marketing a new pharmaceuti-

cal2 in the United States.3 To obtain FDA approval of an NDA, the Food,

Drug, and Cosmetic Act (FDCA) requires the drug sponsor to demonstrate

that the “methods used to manufacture the drug ‘are adequate to preserve

the drug’s identity, strength, quality, and purity’” and that the labeling on

the drug packaging is appropriate.4 Most importantly, however, the FDCA

requires the drug sponsor to set forth “substantial evidence” that demon-

strates the drug is “effective and safe”5 for its “intended use(s).”6 The FDCA

defines “substantial evidence” as “evidence consisting of adequate and well

controlled investigations . . . by experts qualified by scientific training and

experience to evaluate the effectiveness of the drug involved.”7 The NDA

approval process can be broken down into (1) pre-NDA filing activities and

(2) NDA-filing and post-filing activities.

1. Karen E. Keller, Shaw Keller LLP, & Gregory J. Brodzik, Temple University

Beasley School of Law.

2. In practice, a pharmaceutical that is approved under an NDA is referred to as a

“brand” drug. Esther H. Steinhauer, Is Noerr-Pennington Immunity Still a Viable Defense

Against Antitrust Claims Arising from Hatch-Waxman Litigation?, 61 FOOD & DRUG L.J.

679, 680 (2006).

3. See 21 U.S.C. § 355(b)(1) (2006).

4. Brian Porter, Stopping the Practice of Authorized Generics: Mylan’s Effort to Close

the Gaping Black Hole in the Hatch-Waxman Act, 22 J. CONTEMP. HEALTH L. & POL’Y 177,

178 (2005); see 21 U.S.C. § 355(d) (2006). The FDCA regulates the marketing of “drugs,”

defined as items that are “intended for use in the diagnosis, cure, mitigation, treatment, or

prevention of disease in man or other animals.” 21 U.S.C. § 321(g)(1) (2006).

5. Laba Karki, Review of FDA Law Related to Pharmaceuticals: The Hatch-Waxman

Act, Regulatory Amendments and Implications for Drug Patent Enforcement, 87 J. PAT. &

TRADEMARK OFF. SOC’Y 602, 605 (2005); see 21 U.S.C. § 355(d).

6. Carolyne R. Hathaway et al., Looking Abroad: Clinical Drug Trials, 63 FOOD &

DRUG L.J. 673, 675 (2008); see 21 U.S.C. § 355(d).

7. 21 U.S.C. § 355(d).