In a piece recently published in The American Prospect, Alosa Health founder Dr. Jerry Avorn discusses regulatory trends around drug manufacturing and marketing as well as their consequences, making the case that diminishing FDA authority could have harmful effects on patients.
Specifically, he cites the 21st Century Cure Act, which nudges the FDA away from controlled clinical trials and toward measures of evaluation that are narrower in scope, such as whether a drug has an impact on a particular biomarker. Without information gleaned from controlled clinical trials, drugs may come to market absent proof of a net benefit to patients.
In addition to its primary responsibility of evaluating drug efficacy, the FDA also has a responsibility to evaluate marketing claims made by drug manufacturers. Now it appears that authority is also weakening, with the effect that pharmaceutical companies have more leeway in the statements that they can make to consumers. During a 2011 case, for instance, a pharmaceutical sales rep successfully invoked the First Amendment to defend statements that he made promoting a drug for use in clinical situations for which it was not approved.
As Dr. Avorn cautions, the two developments above combined with a president and FDA Commissioner intent on de-regulation as a matter of policy hearken back to a much earlier era in history when medical treatments were not regulated and public health suffered, prompting the government to step in. Read the full article here.