FDA Drug Approvals, Global Trials, and Online Marketing
This paper examines three interconnected issues facing the pharmaceutical industry and its primary regulator, the U.S. Food and Drug Administration. First, it considers the growing trend toward 505(b)(2) drug applications, arguing that market forces will naturally balance these filings with new drug applications over time. Second, it evaluates the practical and ethical concerns surrounding globalized clinical trials, questioning whether cost savings are as significant as claimed and whether the FDA should assume a stronger regulatory role. Finally, it addresses the emerging challenge of regulating online pharmaceutical marketing, with particular attention to third-party digital communications on social media platforms.
- 505(b)(2) Applications and Market Differentiation: Market forces balance 505(b)(2) filings with innovation
- Globalized Clinical Trials: Cost, Ethics, and FDA Oversight: Overseas trials raise cost and ethical concerns
- Online Drug Marketing and Third-Party Digital Communications: FDA struggles to regulate pharmaceutical internet marketing
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What makes this paper effective
- Clearly structured around three distinct regulatory topics, making the argument easy to follow despite covering broad ground.
- Grounds pharmaceutical market analysis in established business theory, specifically Porter's cost leadership versus differentiation framework, lending academic credibility to the economic argument.
- Balances practical regulatory concerns (cost, FDA jurisdiction) with ethical dimensions (consent in overseas trials, teen-targeted online marketing), demonstrating multidimensional analysis.
Key academic technique demonstrated
The paper demonstrates effective use of synthesis across disciplines — combining regulatory policy, business strategy, and bioethics to analyze a single industry. By citing both government reports (Rehnquist, 2001) and foundational business literature (Porter, 1985), the author shows how cross-disciplinary evidence can strengthen applied policy arguments.
Structure breakdown
The paper is organized as three numbered responses to distinct prompts, each functioning as a mini-essay: the first addresses market economics of drug filings; the second critiques the globalization of clinical trials from cost and ethics perspectives; the third analyzes the FDA's challenge in regulating pharmaceutical marketing on the internet and social media. Each section ends with a forward-looking observation about regulatory or market equilibrium.
505(b)(2) Applications and Market Differentiation
The pharmaceutical market is based upon the principle of free will — companies choose what path they wish to follow. Right now, many firms are finding it easier to obtain 505(b)(2) approvals and let their marketing departments determine how to generate revenue from them. While it is true that these types of approvals can push companies in a particular direction, that does not preclude the development of entirely new drugs. Indeed, in a rational market, if companies cannot make money because products are too similar to one another, they will be forced to adopt a strategy of differentiation.
Michael Porter argued that companies must either compete on a cost-leadership basis or a differentiated basis, meaning that only those firms with significant economies of scale can viably pursue the former. Companies will therefore always need to balance new drug applications with 505(b)(2) applications in order to ensure long-term profitability.
The current trend toward 505(b)(2) applications likely reflects the rediscovery of this filing pathway as a viable third option. The value of such filings is apparent to companies, and we are seeing a short- to medium-term rush toward them. Over the long run, however, useful applications will settle to an equilibrium level. Innovation can even be spurred by this process, as firms will work harder to discover, patent, and market all the potential applications of their drugs before competing companies do.
Globalized Clinical Trials: Cost, Ethics, and FDA Oversight
There are two important considerations when examining the issue of globalized clinical trials. First, the cost savings may be overstated. Particularly when the FDA must approve a trial, the same American-based talent is typically required to execute it, and those personnel must be sent overseas to do so. While using foreign researchers can partially address cost concerns, those advantages are already dissipating as Eastern European and Asian economies modernize. Populations in those regions are increasingly less willing to participate as paid test subjects — a development that, while ethically positive, further reduces the financial incentive for conducting trials abroad. Eventually, moving into ever cheaper nations risks encountering less educated populations and less experienced researchers. The FDA will need to draw a clear line: the goal of clinical trials is not to save money, but to test a drug's effectiveness.
Janet Rehnquist recommended that the FDA "exert leadership" on this issue (Rehnquist, 2001). The complexities of globalized clinical trials do not lend themselves to half-hearted regulatory efforts. However, taking a more active role risks transforming the FDA into a regulator of regulators — casting a far wider net over its responsibilities than was ever originally intended. There is nevertheless good cause for the FDA to weigh the practical concerns, as well as the ethical ones, when considering how to scale back reliance on non-U.S. clinical trials.
Works Cited
Rehnquist, J. (2001). The globalization of clinical trials. Department of Health and Human Services. Retrieved November 14, 2009 from
Porter, M. (1985). Competitive Strategy.
Daniloff, C. (2009). Drug companies target teens online. BU Today. Retrieved November 14, 2009 from
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