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Public Citizen filed comments supporting a Food and Drug Administration (FDA) draft guidance, in which the FDA declared that it would no longer grant orphan drug designation to drugs for use in pediatric subpopulations of common diseases or conditions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.

[Created on 1/11/2018]

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.

[Created on 1/10/2018]

Public Citizen petitioned the Food and Drug Administration (FDA) to ban the use of the cancer treatment ingredient cesium chloride in pharmacy compounding because of serious health risks. FDA staff determined more than 18 months ago that cesium chloride has not been shown to be effective for “the prevention or treatment of any form of cancer,” presented “serious safety concerns,” and is “not safe for human use.”

[Created on 12/6/2017]

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 2017.
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.

[Created on 11/20/2017]

Public Citizen submitted comments to the Food and Drug Administration (FDA) pointing out that a study commissioned by the agency to justify its potential proposal to decrease the amount of risk information required to be disclosed in prescription drug direct-to-consumer (DTC) broadcast ads is fundamentally incomplete, flawed, and overly narrow in scope. Public Citizen urged the agency to issue a legally binding final rule regarding DTC broadcast ads that would: 1) maintain its current requirements regarding which risks must be disclosed, while requiring that severe, serious, or actionable risks be disclosed more prominently; 2) require all risk information to be disclosed in both audio and visual formats; and 3) ban the use of distracting imagery and sounds during the disclosure of risk information.

[Created on 11/20/2017]

Public Citizen petitioned the Food and Drug Administration (FDA) to ban the sale of olmesartan medoxomil – an angiotensin II receptor blocker (ARB) found in the widely prescribed hypertension medications marketed under the brand names Azor, Benicar, Benicar HCT and Tribenzor, as well as in other generic versions – because it can cause a severe gastrointestinal disorder that leads to severe and chronic diarrhea, vomiting, abdominal pain and weight loss.

[Created on 11/15/2017]

Public Citizen calls on the European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) to follow the example of Sweden’s Medical Products Agency and require the immediate removal of hydroxyethyl starch (HES) solutions from the market in Europe because the solutions cause kidney failure, bleeding, and death and there are safer alternatives available. Recent drug utilization studies in 10 European Union countries indicate the futility of the PRAC’s 2013 decision to restrict the use of HES products in Europe.

[Created on 11/14/2017]

Public Citizen urged the Food and Drug Administration (FDA) to issue expanded guidance that includes a discussion of the types of clinical investigations for which the agency might consider an institutional review board’s (IRB’s) waiver of informed consent to be appropriate from both an ethical and regulatory perspective.

[Created on 9/22/2017]

In a post to Yale University’s CRITical Thinking blog, we discuss key features of a pro-patient, pro-public health agenda for the regulation of medical products. The blog post is derived from a presentation made at the June 2017 international conference hosted by the Yale Collaboration for Research Integrity and Transparency (CRIT) titled “Ensuring Safety, Efficacy, and Access to Medical Products in the Age of Global Deregulation.”

[Created on 9/13/2017]

In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Medical Imaging Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA adopt the approach of the European Medicines Agency and ban and restrict linear gadolinium-based contrast agents used in MRIs because they can remain deposited in the brain for months or even years and, with certain exceptions, offer no unique benefits over potentially safer, more widely used macrocyclic gadolinium-based products.

[Created on 9/8/2017]

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