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Recent Blog Posts in May 2010 |
| May 11, 2010 |
| FDA Announces “Bad Ad Program” to Help Health Care Providers Detect and Report Misleading Drug Ads |
| Posted By DeCarli Law |
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Today, the U.S. Food and Drug Administration announced the launch of what it calls the “Bad Ad Program.” The program is designed to educate health care providers about their role in ensuring that prescription drug advertising and promotion is truthful and not misleading.
The program is aimed at drug ads that target doctors and other health care providers. The pharmaceutical industry spends three times as much on advertising directed at health care professionals as it spends on advertising directed at consumers. Advertising directly to health care professionals is called “detailing,” and most frequently occurs in locations such as medical offices, hospitals, and pharmacies, as well as at medical meetings and symposia.
A document released today by the FDA describes the main purpose of the Bad Ad Program as raising “awareness among health care professionals about the importance of helping FDA in its efforts to prevent misleading promotion of prescription drugs.” According to Thomas Abrams, director of the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC), “the Bad Ad Program will help health care providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency.”
When reports of misleading ads are filed, the DDMAC will determine whether it meets the criteria necessary for taking regulatory action. If the DDMAC determines the ad to be a violation, it will move forward with an appropriate enforcement action, which could include sending a Warning Letter or referring the matter to law enforcement for a criminal investigation.
Although the Bad Ad Program is mainly aimed at health care professionals, anyone can submit a complaint to the FDA. The FDA has a similar educational campaign designed to educate consumers about misleading drugs advertisements. This program is called EthicAd and may be accessed on the internet HERE.
If you believe you have been injured by a prescription drug or over-the-counter drug, you also can report this to the FDA HERE. This is not necessary to preserve your legal rights, but it is the right thing to do, because it can bring dangerous drug side effects to the attention of the FDA, and make sure the FDA is aware how dangerous a particular drug is.
FDA Documents on the Bad Ad Program:
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| May 10, 2010 |
| Federal Judge Rejects GE Healthcare Arguments to Exclude Expert Testimony on Cause of NSF |
| Posted By DeCarli Law |
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A recent court ruling has strengthened the legal position in federal court of those suffering from Nephrogenic Systemic Fibrosis (NSF). A federal judge rejected the arguments of defendant GE Healthcare that plaintiffs should not be allowed to present expert testimony on how GE Healthcare’s brand of gadolinium-based contrast agent, Omniscan, causes NSF.
Some NSF victims have filed their claims in federal court, and their claims have been consolidated using a procedure known as multi-district litigation (MDL). The NSF MDL is pending in the United States District Court for the Northern District of Ohio. In federal court, scientific evidence must be sufficiently reliable in order for it to be presented to a jury. General Electric Healthcare claimed that the evidence presented by NSF victims on how Omniscan causes NSF was not sufficiently reliable for the jury to hear the evidence.
The federal court rejected GE Healthcare’s argument, and ruled that evidence supporting the “free gadolinium” theory could be presented to the jury. In rejecting GE Healthcare’s request, the Court noted that GE’s own experts acknowledge that it is “the prevailing theory in the scientific community.” To read the entire order, go HERE
. To learn more about how Omniscan and other gadolinium-based contrast agents cause NSF, go HERE
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Nephrogenic Systemic Fibrosis (NSF), also known as Nephrogenic Fibrosing Dermopathy (NFD), is an incurable disease characterized by hardening of the skin and other body tissues. The only known cause of NSF/NFD are the gadolinium-based contrast agents used in a medical procedure such as an MRI, MRA, angiogram/angioplasty, and CT scan (CAT scan), among others. Diabetics and others with severe kidney impairment are most at risk of developing NSF. The attorneys at DeCarli Law are familiar with NSF, and help people who suffer from NSF assert their legal rights. If you believe you or a loved has NSF, feel free to contact the gadolinium lawyers at DeCarli Law for a free, no-obligation telephone consultation.
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