Health Research Group Publications
Founded in 1971 by Sidney Wolfe, M.D. and Ralph Nader, Public Citizen’s Health Research Group promotes research-based, system-wide changes in health-care policy and drug safety. The work that we have done since 1995 is listed on this page in chronological order.
Public Citizen submitted a supplement to its petition the Food and Drug Administration (FDA) to ban the sale of all medication containing the widely prescribed angiotensin II receptor blocker (ARB) olmesartan medoxomil because it can cause a severe gastrointestinal disorder that leads to severe and chronic diarrhea, vomiting, abdominal pain and weight loss. Since the submission of our petition, a new large cohort study was published that provides additional evidence showing that use of olmesartan is associated with a higher rate of sprue-like enteropathy compared with the use of other ARBs.
Public Citizen sent a letter to Senator Chuck Grassley urging him to broadly examine the adequacy of the Office for Human Research Protections’ (OHRP’s) compliance oversight activities and demand that the agency cease abusing its discretion when deciding whether to initiate evaluations of noncompliance allegations. The letter noted that OHRP now routinely bypasses its own procedures for investigating allegations of misconduct, which in turn signals to the research community that there is little chance the agency will investigate even serious allegations of regulatory violations.
Public Citizen expressed concerns with the proposal to grant two years of exclusivity for certain over-the-counter (OTC) drugs that is included in the September 11, 2017, House of Representatives’ discussion draft of the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018. While Public Citizen supports many of the measures included in the Act that would enable the Food and Drug Administration to better ensure that OTC drugs are safe and effective, we are concerned that the proposal to grant two years of exclusivity for certain OTC drugs could have negative repercussions for consumers.
Public Citizen sent a letter to members of U.S. House of Representatives’ Energy and Commerce Committee urging them to oppose legislation that would further erode the restrictions on the promotion of drugs for unapproved (off-label) uses that have been approved by the Food and Drug Administration for at least one use. The bill would threaten patient health and safety by undermining the current regulatory regime for ensuring that drugs are safe and effective for each intended use.
Public Citizen advocated that the Food and Drug Administration follow the lead of its European and Canadian counterpart agencies and: 1) notify the public when an application to market a new drug or new use for an already-marketed drug is rejected by the agency or withdrawn by the company; and 2) release its analyses of data submitted in support of such rejected or withdrawn applications.
In an invited commentary, Dr. Michael Carome, director of Public Citizen’s Health Research Group, explains why so-called “right-to-try” legislation that was passed by the U.S. Senate and is now being considered by the U.S. House of Representatives would create a dangerous, uncharted pathway for patients to access experimental medications. The legislation would effectively undermine the FDA’s safety rules regarding the use of experimental drugs outside the context of a clinical trial, putting countless patients at risk.
Public Citizen’s Health Research Group published a commentary in the Journal of Law, Medicine & Ethics advocating that the Food and Drug Administration (FDA) follow the lead of its European and Canadian counterpart agencies and: 1) notify the public when an application to market a new drug or new use for an already-marketed drug is rejected by the agency or withdrawn by the company; and 2) release its analyses of data submitted in support of such rejected or withdrawn applications.
Public Citizen applauds the decision by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee to recommend removing all hydroxyethyl starch (HES) intravenous (IV) solutions from the market, although this action comes nearly five years too late. The Food and Drug Administration (FDA) must now follow suit with an immediate ban on HES solutions in the U.S.
Public Citizen filed comments supporting a Food and Drug Administration (FDA) draft guidance, in which the FDA declared that it would no longer grant orphan drug designation to drugs for use in pediatric subpopulations of common diseases or conditions unless: 1) The disease in the pediatric population constitutes a valid orphan subset, or 2) the disease in the pediatric subpopulation is a different disease from the disease in the adult population.
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Bone, Reproductive and Urologic Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA reject Lipocine’s oral testosterone undecanoate capsules (Tlando) because of serious safety concerns.