I frequently read comments from pundits and politicians decrying the US drug regulatory system, specifically the FDA. Many of these people, reading from the same PR playbook, will try to convince you that regulation is the primary factor in stifling innovation.
But based on history, I am convinced that without adequate government regulation, companies in a number of industries, including pharmaceuticals, would run roughshod over the citizenry in an effort to maximize their profits. It’s painful to see how the drug industry has sullied its once excellent reputation by employing a variety of unethical practices, as has been widely reported.
Magazine publisher Steve Forbes recently opined how regulation was destroying the pharmaceutical industry and how it might “kill millions of us.” He claims that the declining number of new drug approvals is not a result of the failure of the industry to innovate but instead “the chief villain is the FDA.” His “insight” that the industry’s notable lack of success in developing a new class of antibiotics is a failure of the government (both the FDA and the NIH are blamed) is both reckless and overly simplistic. Forbes fails to mention the fact that many drug companies have chosen to maximize their profits by investing in drugs for chronic conditions that need to be taken for years (e.g. heart disease, arthritis) over short term medicines like antibiotics. A more balanced view of the problem can be found in a recent report on what happens “When the Drugs Don’t Work”.
The FDA is not close to being perfect. It responds to shifting political winds and is forced to make high-stakes decisions under great scrutiny while being chronically under-funded. However, I hate to imagine what the marketplace would look like without regulatory agencies balancing out the enormous marketing and lobbying efforts employed by drug companies both large and small. Let’s review some of the less savory and injudicious practices employed by drug makers before numerous laws were passed to safeguard consumers. I’ll focus on just a few chapters from the past century of drug development to illustrate problems caused by a lack of regulation.
We want our drugs to be both safe and effective. History is filled with
