Could go either way. Probably won’t have any effect on whether or not injured consumers can sue if they took generics. Hamburg said FDA has collected $125 million in GDUFA fees for 2013 so far. However, she noted, the budget situation and sequestration have “significant implications” for using generic user fees and budget dollars. Budget… Continue Reading
Category Archives: Politics
Subscribe to Politics RSS FeedSecret Payments to Doctors Will End in 2013
Posted in PoliticsEarlier, I wrote about how doctors aren’t disclosing their financial ties to the pharmaceutical industry. Turns out that they soon will be: As part of the Patient Protection and Affordable Care Act, drug, device and medical supply companies are required to list payments worth $10 or more to doctors in a public database that can… Continue Reading
Secret payments to doctors put patient lives at risk
Posted in Drug Studies, PoliticsA big part of what I do for a living is investigate the safety of drugs and medical devices. That means I spend time reading studies about the safety of a specific drug. One of the things I look at is the author of the study. If the author of the study discloses that he… Continue Reading
Even under Obama, politics trumps science at the FDA & USDA
Posted in PoliticsCall me crazy, but it seems to me that political back-scratching shouldn’t determine whether or not consumers eat tainted meat or take defective drugs: Scientists and inspectors at the federal agencies responsible for food safety say they face political and corporate interference with their work, according to a survey released Monday by the Union of… Continue Reading
Will the FDA Finally Get Subpoena Power & Recall Authority?
Posted in FDA Regulation, PoliticsDid you know that the FDA doesn’t have subpoena power? That’s the power to make a company hand over a document. Every single attorney in the U.S. can subpoena a document from a pharmaceutical company, but the FDA (which is supposed to regulate pharmaceuticals) doesn’t have that power. Citing a recent spike in pharmaceutical recalls,… Continue Reading
Enading Pay-to-Delay deals will save taxpayers billions of dollars… and may save some lives, too.
Posted in Generic Drugs, PoliticsPay-to-delay deals help no one and nothing outside of the bottom lines of a few big pharmaceutical companies. Here’s hoping they go away soon… FOR TOO LONG, pay-for-delay settlements have been an accepted part of the health-care landscape. In these deals, a brand-name drug manufacturer pays a generic competitor to delay its entry into the… Continue Reading
Bipartisan Push To Remove Avandia From The Market
Posted in Misc. Drugs, PoliticsI generally tend to support Democrats because they are usually more attentive to the needs of everyday Americans vs. those of the drug companies. One notable exception is that of Republican Chuck Grassley. He’s been a thorn in the side of many drug companies, so I’m not surprised that he’s so involved in the controversy… Continue Reading
Pay-To-Delay Drug Deals Dying Due To Democrats
Posted in PoliticsYou tell me if this sounds competitive: Major pharmaceutical company develops new drug. Minor pharmaceutical company wants to bring generic version on the market at a much lower price. Major pharmaceutical company pays minor pharmaceutical company not to release the drug. In the eyes of some pharmaceutical industries, and some Republicans, that is a competitive… Continue Reading