On February 14, 2012 Rep. Henry A. Waxman, Rep. Edward J. Markey, and Rep. Diana DeGette wrote to NIH Director Francis Collins and FDA Commissioner Margaret Hamburg expressing concern over a recent report documenting the underreporting of results of clinical drug trials. The report, published in the British Medical Journal, found that researchers and pharmaceutical companies routinely [...]
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J&J Faces FDA Inquiry After Allegedly Selling Defective Insulin Pumps
I was diagnosed with type 1 diabetes at the age of 7. I use a medical device called an insulin pump to manage my diabetes. For diabetics, insulin pumps are critical for maintaining one’s health. These revolutionary devices are time-saving and life-saving solutions, helping diabetics electronically control their blood sugar levels without the constant need [...]
Big Pharma Payments To Docs Decreasing
ProPublica, an investigative journalism website, has been examining the financial connection between doctors and drug companies since 2010. What they found was no surprise: a number of doctors take money from drug companies and medical device makers in exchange for promoting their products. Doctors rely on drug company reps to keep them informed about the [...]
FAQ Friday #1 – FDA’s Role In Drug Approval
What does it mean when a drug is FDA approved? It means that a drug is safe and effective for use. The primary role of the FDA is to ensure that prescription drugs and medical devices are safe and effective. The FDA determines the safety and efficacy of a product by reviewing the results of [...]
Medical Device Manufacturer Caught Red Handed, Patients Still Lose
Bottom-line: Medtronic pays doctors to recommend defective devices. Once those defective devices hurt the patient that patient cannot sue the manufacturer. Medtronic Inc. agreed to pay the United States $23.5 million to resolve allegations that it violated the False Claim Act by using physician payments related to post-market studies and device registries as kickbacks to [...]
Pay For Positive Results, Money Talks Science Walks
Bottom-Line: Clinical Trial’s Funded By Big Pharma Are More Likely To Provide Positive Results The primary role of the FDA in the drug approval process is to simply review the results of clinical trials. Since the FDA does not perform clinical trials, it must largely rely on data from clinical trials organized and paid for [...]
FDA Panel Wants More Risk Information On Yaz Pills
Bayer’s Yaz, Yasmin contraceptive products will stay on the market. However, the FDA panel reviewing the products want more information about the possible increased risk of blood clots. What happens now? The advisory committee made their recommendation but the final approval of the new labeling comes from the FDA itself. We will have to wait [...]
Agency Overrules FDA’s Recommendation That The Morning After Bill Be Available Without A Prescription
In a move that smacks of politics rather than safety, the Department of Health and Human Services overruled the FDA’s decision to make the “morning after pill” or Plan B available over the counter. The sign that this move is more political than safety related, the Secretary of DHHS issued a statement containing the following: [...]
Pfizer Smacked With $72.6 Million In Damages In Breast Cancer Case
Dec. 6 (Bloomberg) — Pfizer Inc. must pay $72.6 million in damages to three women who said they developed breast cancer after taking the company’s menopause drugs, a Philadelphia jury decided. Jurors today in state court deliberated over two days before finding hormone-replacement drugs made by Pfizer’s Wyeth and Pharmacia Upjohn units were responsible for [...]
No Generic Drug Preemption For “Dear Doctor” Letters
A Nevada State Court Judge ruled that plaintiffs can sue generic drug manufacturers despite the Supreme Court’s recent ruling protecting drug companies from lawsuits in PLIVA, Inc. v. Mensing
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The Bark is the blog of Mark Sadaka. Mark is the founder of Law Offices of Sadaka Associates LLC, advocate and scientist.
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