Tag: FDA
Scott Gottlieb Confirmed as Head of the FDA
From Pacific Standard: This past Tuesday, the Senate confirmed Scott Gottlieb as head of the Food and Drug Administration.
"Although some Senate Democrats had worried about...
Change in Chicago: Playing Go
The jury was out for days. And when they came back it became clear they were wrestling with the issue of who to blame. This was like playing Go, where it can look like the black counters on the board have white encircled until white puts down one more piece and all of a sudden it wins.
Dear Scott Gottlieb: Add New Warnings to Paxil Labels
From STAT: Scott Gottlieb, Trump's pick to lead the FDA, should consider pursuing a stronger warning label for the antidepressant Paxil. Paxil's label currently does...
Trump’s Pick to Oversee Big Pharma has Ties to Opioid Industry
From The Intercept: Newly released documents show that Dr. Scott Gottlieb, President Trump's nominee to lead the FDA, has received almost $45,000 in speaking fees...
Researchers Make Recommendations to Improve FDA Transparency
Organizations, advocates, scholars, and practitioners had a chance to give feedback regarding FDA processes.
Show Drugs Work Before Selling Them
From Nature: FDA regulation plays a major role in the functioning of our economy. Trump's plans to deregulate the FDA will not only put...
Trump Chooses Gottlieb to run FDA; Big Pharma Relieved
From Reuters: President Trump has selected Dr. Scott Gottlieb, a conservative health policy expert with deep ties to the pharmaceutical industry, to lead the FDA.
Article...
FDA Approved Drugs may Become Riskier
From the Center for Health Journalism: President Trump's plans to speed up the process of FDA drug approvals, in combination with the increase of off-label...
How big Pharma’s Lust for Profit Harms Their Customers
From AlterNet: The increasing pace at which the FDA is approving new drugs can lead to significant risks to patient safety. Drugs that once would have...
I do Hate to Tell you This, but…
In this commentary for In the Pipeline, Derek Lowe highlights the results from a recent FDA report showing that the vast majority of all drugs...
Cancer Drug Offers a Cautionary Tale of Deregulating the FDA
To illustrate the dangers of Trump's plans to deregulate the FDA, Susan Perry from MinnPost provides a cautionary tale about Tarceva, a drug approved by the...
Trump Wants to Blow up the FDA
From STAT: President Trump plans to decrease regulations on the Food and Drug Administration. Medical experts and healthcare professionals have expressed concerns that this could expose...
âTrump is Considering a Radical to Lead FDA. Thatâs Dangerous for...
For STAT, Ed Silverman writes, âthe incoming Trump administration may seek to undo a decades-old standard of evaluating drugs for effectiveness â to the detriment of...
âHouse Passes Controversial Medical Funding ‘Cures’ Billâ
âDemocrats and consumer groups were upset with the bill's streamlining of some Food and Drug Administration processes, including making it easier for companies to...
FDA Safety Warning For Citalopram Did Not Improve Outcomes for Vets
Instead of reducing risk, the dose reduction recommendation made by the FDA in their safety message was associated with an increase in hospitalizations.
“A Frenzy Of Lobbying On 21st Century Cures”
Kaiser Health News and NPR report on the immense lobbying effort aimed at passing the "21st Century Cures" Act which would fast-track FDA approval...
“21st Century Cures Act will get Vote this Week”
Several members of Congress spoke this weekend signaling that they were ready to vote on legislation designed to speed federal approval of new drugs...
âFormer FDA Official Settles Insider Trading Chargesâ
For STAT, Ed Silverman reports that Gordon Johnston, a former FDA official, has agreed to a settlement after being accused of insider trading. âJohnston,...
Antidepressants Increase the Risk of Suicide and Violence at All Ages
Although the drug industry, our drug regulators and leading psychiatrists have done what they could to obscure these facts, it can no longer be doubted that antidepressants are dangerous and can cause suicide and homicide at any age.
âFDA Issues Guidelines for Female Libido Pills After Learning Some Hard...
From STAT:Â It âlooks like the FDA is using this guidance to keep another company from trying to get a female sexual desire drug approved...
âIs the FDA Too Cozy With Drug Companies?â
TIME magazine covers a new report suggesting that many medical reviewers who work for the FDA go on to work for the drug companies they...
âDoes the FDA have a High Enough Standard for Drug Approvals?â
Last week STAT hosted a panel of experts, asking âIs the Food and Drug Administrationâs approval process broken?â
Article âÂ
âThe Drug Industry Thrives on the Revolving Doorâ
Sheila Kaplan reports for STAT on a new study finding that more than half of FDA drug reviewers went on to work for the...
âDid the FDA set âa Dangerous Precedentâ with Latest Drug Approval?â
STAT reports that the latest drug approval by the FDA âmay have set a precedent that could rocket through the health care system, opening the...
âFDA Panel Votes to Remove Serious Warning from Pfizerâs Smoking Cessation...
This week an FDA advisory panel decided to remove warnings of serious psychiatric side effects from the Chantix product label. âIn making its recommendation,...