Drug Review, Approval, Recall, Accountability
- U.S. Food & Drug Administration (FDA)FDA website
- Foreword / Vision / Mission / ValuesFDA (U.S. Food & Drug Administration)
- What We DoFDA
- Dr. Frances Kathleen Oldham Kelsey
U.S. National Library of Medicine - Protecting the Public: Profile of Dr. Frances Oldham Kelsey"That Dr. Frances Oldham Kelsey saved countless lives and prevented numerous physical deformities of infants and children is a remarkable accomplishment in any career. More remarkable still is the fact that she accomplished this feat not through the discovery of a cure, the development of an innovative surgical procedure, or the invention of a life-saving device. Rather, it was Dr. Kelsey's professional behavior—her unwillingness to compromise the priorities of patient health and safety—that single-handedly averted an appalling tragedy nearly thrust upon an unsuspecting American public." -- AMA Journal of Ethics, Karen Geraghty, Virtual Mentor. 2001;3(7): doi: 10.1001/virtualmentor.2001.3.7.prol1-0107.
- Kefauver-Harris Amendments Revolutionized Drug Development"Landmark legislation was signed into law by President John F. Kennedy that established the scientific safeguards used today by the Food and Drug Administration (FDA) to ensure that consumers will not be the victims of unsafe and ineffective medications." -- FDA
FDA in the Twenty-First Century by Call Number: e-BookISBN: 9780231540070Publication Date: 2015-09-08
Quality risk management in the FDA-regulated industry by Call Number: e-BookISBN: 9781953079312Publication Date: 2017
"Drug discovery is not for the faint of heart. On average, it takes nearly a decade to produce a new drug, and less than 10% of candidates make it to the finish line—patient access." -- https://www.pfizer.com/art-creating-new-medicines
"The Food and Drug Administration has gotten faster at approving new prescription drugs over the past four decades, but the evidence it relies on in making those decisions is getting weaker, according to new research published Tuesday. As a result, there are more cures and treatments on the market but less proof that they are safe and effective." -- NPR, All Things Considered 1/14/2020
"While the number and speed of drug approvals have been increasing over time, so have the number of drugs that end up having serious safety issues coming to light after FDA approval." -- University of Connecticut, UConn Today 5/21/2021
- FDA no longer needs to require animal tests before human drug trialsScience.org, by Meredith Wadman, 1/10/2023
- Development & Approval Process (FDA)U.S. Food & Drug Administration (FDA)
- FDA's Drug Review Process: ContinuedU.S. Food & Drug Administration (FDA)
- FDA Approves New Oncology Therapies Faster Than EMA, Study Finds"Only 20% of drugs approved with a surrogate end point later showed improvement in overall survival. Previous studies have shown that drugs receiving accelerated approval by the FDA are twice as likely to receive a black box warning indicating serious risk or to be withdrawn from the market." -- AJMC, Lindsey Mulrooney, 6/13/2022
- The Timing of Cancer Drug Approvals in the United States and Europe" Over the past decade, the FDA approved oncology drugs twice as fast as the EMA, more often through accelerated pathways, and often prior to study publication.... Although the speed of FDA review times and subsequent number of approvals have increased over time, the proportion of cancer drugs that improve survival has declined." -- MP, Desai A, Gyawali B, et al. Cancer therapy approval timings, review speed, and publication of pivotal registration trials in the US and Europe, 2010-2019. JAMA Netw Open. 2022;5(6):e2216183. doi:10.1001/jamanetworkopen.2022.16183
- There's a Reason 90% of Drugs Fail Clinical Trials, And We Can Fix ItSciencealert.com, Duxin Sun, The Conversation 2/24/2022
- Delinking ReimbursementSachs, Rachel, Delinking Reimbursement (February 1, 2018). Minnesota Law Review, Forthcoming, Washington University in St. Louis Legal Studies Research Paper, Available at SSRN: https://ssrn.com/abstract=3117069
- Approving new drugsBy John L. LaMattina, Science, 2/24/2017, v.355, no.6327, p.777 https://doi.org/10.1126/science.aam9914
- FDA DRUG APPROVAL: Application Review Times Largely Reflect Agency Goals"Four key features of new drug applications (NDA) are linked to the time the Food and Drug Administration (FDA) takes to complete initial reviews of NDAs. Three key NDA features determine the time frames for initial review that would meet FDA’s goals under the Prescription Drug User Fee Act (PDUFA) and its reauthorizations, which authorize FDA to collect user fees from drug sponsors" -- “FDA DRUG APPROVAL: Application Review Times Largely Reflect Agency Goals.” GAO Reports, Apr. 2020, pp. 1–42. EBSCOhost, search.ebscohost.com/login.aspx?direct=true&AuthType=shib&db=f5h&AN=142593591&site=eds-live.
- THE FDA'S ACCELERATED APPROVAL PROCESS: DOES THE PHARMACEUTICAL INDUSTRY HAVE ADEQUATE INCENTIVES FOR SELF-REGULATION?Orlando, Vivian I. “The FDA’s Accelerated Approval Process: Does the Pharmaceutical Industry Have Adequate Incentives for Self-Regulation?” American Journal of Law & Medicine, vol. 25, no. 4, Dec. 1999, p. 543. EBSCOhost, doi:10.1017/s0098858800007279.
- MedWatch Online Voluntary Reporting Form"Health professionals, consumers and patients can voluntarily report observed or suspected adverse events for human medical products to FDA." -- FDA (U.S. Food & Drug Administration)
- V-safe After Vaccination Health CheckerCDC, updated 11/9/2021
- VAERS (Vaccine Adverse Event Reporting System)VAERS is co-sponsored by the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA), agencies of the U.S. Department of Health and Human Services (HHS)
- Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010Downing, Nicholas S., et al. “Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010.” JAMA: Journal of the American Medical Association, vol. 317, no. 18, May 2017, pp. 1854–1863. EBSCOhost, doi:10.1001/jama.2017.5150.
- THE ADEQUACY OF FDA TO ASSURE THE SAFETY OF THE NATION'S DRUG SUPPLY"PDUFA requires the FDA to quickly bring new drugs to the market. In its rush to approve new drugs, the FDA's ability to ensure a safe drug supply has been greatly compromised. Prior to PDUFA, seldom was the FDA forced to withdraw drugs from the market; within the first 3 years of PDUFA, seven drugs, resulting in more than a thousand deaths, had been removed. Those seven deadly drugs, rushed for approval under PDUFA, were not needed to save lives." -- Hearings before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce House of Representatives One Hundred Tenth Congress First Session, Feb. 13, March 22, 2007. Serial No. 110-5. U.S. Government Printing Office, 2007.
- A potentially serious adverse effect of GLP-1 receptor agonists"The risk of chronic intestinal obstruction in humans cumulates over time, with the highest occurrence appearing 1.6 years following GLP-1RA treatment. However, clinical trials on GLP-1RAs usually do not last for more than a year..." -- Jinmiao Lu, Hao Liu, Qingtong Zhou, Ming-Wei Wang, Zhiping Li, A potentially serious adverse effect of GLP-1 receptor agonists, Acta Pharmaceutica Sinica B, 2023
- Hollywood weight-loss drugs could trigger deadly side effect, researchers claim [GLP-1 receptor agonists]New York Post, by Jane Herz, 3/6/2023
"Human Drugs regulatory activities account for 33 percent of FDA’s budget; 65 percent of these activities are paid for by industry user fees." -- Fact Sheet: FDA at a Glance (a Food and Drug Administration publication)
- Epistemic Corruption, the Pharmaceutical Industry, and the Body of Medical Science"Funding is rarely just funding. Most pharmaceutical company-sponsored clinical trials are designed, organized, audited, analyzed, and written up by the companies and their hired subcontractors." -- https://doi.org/10.3389/frma.2021.614013
- The Biopharmaceutical Industry Provides 75% Of The FDA's Drug Review Budget. Is This A Problem?Forbes.com, John LaMattina,
- Debate Builds Over Drug Companies' Fees to FDAMedicinenet.com (a WebMD owned site). Article by Steven Reinberg. 4/13/2007.
"Dr. Jerry Avorn, a professor of medicine at Harvard Medical School and chief of the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women's Hospital in Boston, states that renewal of PDUFA should be predicated on fixing what he sees as the dangerous shortcomings in the law. In particular, he is calling for more requirements for safety studies and better oversight of adverse drug effects ... We are learning that the PDUFA is having important negative, unintended consequences," he said. "Drugs are being rushed through, not getting the attention they deserve. And the culture within the FDA has changed, seeing industry as the client they need to please. "People within FDA say they feel they are under pressure to not find safety problems with drugs, and make approval decisions they would not have made if they were not under the gun," he added." -- https://www.medicinenet.com/script/main/art.asp?articlekey=80473 - FDA Depends on Industry Funding; Money Comes with “Strings Attached”POGO.org, (Project On Government Oversight), David S. Hilzenrath, 12/1/2016
- FDA’s Reliance on User FeesYale Journal on Regulation, blog entry by Erika Lietzan, 9/4/2017
- FDA Executive Officer on Hidden Camera Reveals Future COVID Policy"There's almost a billion dollars a year going into FDA's budget from the people we regulate." Christopher Cole, FDA employee, Project Veritas hidden camera video, 2/15/2022
- Undisclosed industry payments rampant in drug-trial papers"One in four Australian medical researchers involved in drug trials failed to declare money they had received from pharmaceutical companies...Almost half of 120 clinical trials had missiing or incomplete conflict of interest (COI) data from at least one Australian author." -- Watson, C. (2022). Undisclosed industry payments rampant in drug-trial papers. Nature.
- FDA's revolving door: Companies often hire agency staffers who managed their successful drug reviews"Through web searches and online services such as LinkedIn, however, Science has discovered that 11 of 16 FDA medical examiners who worked on 28 drug approvals and then left the agency for new jobs are now employed by or consult for the companies they recently regulated. This can create at least the appearance of conflicts of interest."-- Science.org, by Charles Piller, 7/5/2018
- Hidden conflicts? Pharma payments to FDA advisers after drug approvals spark ethical concerns"Science investigation of journal disclosures and pharmaceutical funding records shows potential influence on physician gatekeepers "-- Science.org, by Charles Piller, Jia You, 7/5/2018
- Fact Sheet: Prohibited Financial Interests for FDA EmployeesU.S. Food & Drug Administration (FDA)
- Prohibited Financial Interests for FDA EmployeesU.S. Food & Drug Administration (FDA) , content current as of: 7/22/2020
- Appointment of Pfizer exec to health funding body criticizedCBC News, Anna Sharratt, 11/27/2009