FDA & Prescription Drugs

• Study Documents Outbreak of Fungal Eye Infections Among Contact Lens Wearers in Singapore

  Staff Writer | July 16, 2006 10:02 AM | 0 CommentsDenver, CO

  According to The Doctor's Guide News, officials in Singapore have reported a dramatic increase in the reported cases of Fusarium Keratitis, a severe fungal eye infection possible linked to Bausch and Lomb ReNu with MoisureLoc. A study by the Singapore Eye Research Institute examined contact lens wearers rate of Fusarium keratitis during a 15-month period. Of the contact lens wearers diagnosed...

• New Rules on Prescription Drug Preemption--A Conclusion or Two

  Staff Writer | July 11, 2006 9:11 PM | 0 CommentsDenver, CO

  As a regulatory agency, the authority of the FDA is limited to the creation of regulations which implement the responsibilities delegated to FDA by Congress. Since Congress did not expressly preempt state law tort claims, FDA has no authority to establish express preemption.FDA has no authority to interpret the law. The doctrines of conflict preemption are judicially created and judicially...

• New Rules on Prescription Drug Preemption--FDA's Concession About State Court Claims

  Staff Writer | July 10, 2006 9:09 PM | 0 CommentsDenver, CO

  FDA recognizes that FDA's regulation of drug labeling will not preempt all State law actions. The Supreme Court has held that certain State law requirements that parallel FDA requirements may not be preempted (Medtronic, Inc. v. Lohr, 518 U.S. 4790, 495 (1996)) (holding that the presence of a State law damages remedy for violations of FDA requirements does not impose an additional requirement...

• New Rules on Prescription Drug Preemption--FDA Conclusions on Preemption

  Staff Writer | July 09, 2006 9:02 PM | 0 CommentsDenver, CO

  Consistent with its court submissions and existing preemption principles, FDA believes that at least the following claims would be preempted by its regulation of prescription drug labeling:1. Claims that a drug sponsor breached an obligation to warn by failing to put in Highlights or otherwise emphasize any information the substanc4e of which appears anywhere in the labeling;2. Claims that a...

• New Rules on Prescription Drug Preemption--State Law Actions and FDA's Statutorily Prescribed Role

  Staff Writer | July 08, 2006 9:00 PM | 0 CommentsDenver, CO

  State law actions also threaten FDA's statutorily prescribed role as the expert federal agency responsible for evaluating and regulating drugs. State actions are not characterized by centralized expert evaluation of drug regulatory issues. Instead, they encourage, and in fact require, lay judges and juries to second-guess the assessment of benefits versus risks of a specific drug to the...

• New Rules on Prescription Drug Preemption and State Law

  Staff Writer | July 07, 2006 8:57 PM | 0 CommentsDenver, CO

  State law requirements can undermine safe and effective drug use in other ways and over-warning, just like under-warning, can similarly have a negative effect on patient safety and public health.State law actions can rely on and propagate interpretations of the act and FDA regulations that conflict with the agency's own interpretations and frustrate the agency's implementation of its statutory...

• Clozapine: Anti-Psychotic Drug Linked to Metabolic Syndrome

  Staff Writer | July 07, 2006 10:49 AM | 0 CommentsDenver, CO

  An interesting report on the Ivanhoe Newswire reports that patients at the University of Rochester Center in New York who have taken Clozapine have drastically greater rates of metabolic syndrome, which increases their chance of getting diabetes, stroke and heart diseases. Clozapine is the only product that the Food and Drug Administration approves for treatment of suicidal behavior.

• New Rules on Prescription Drug Preemption and Preemption Principles

  Staff Writer | July 06, 2006 8:49 PM | 0 CommentsDenver, CO

  New Rules on Prescription Drug Preemption and Preemption PrinciplesFDA believes that under existing preemption principles, FDA approval of labeling under the act, whether it be in the old, or new format, preempts conflicting or contrary State law. Indeed, the Department of Justice (DOJ), on behalf of FDA, has filed a number of amicus briefs making this very point. In order to more fully...

• Ketek Associated with Severe Liver Damage and Death

  Staff Writer | July 06, 2006 7:04 PM | 0 CommentsDenver, CO

  We'd like to alert you to recent developments concerning Ketek, a popular antibiotic marketed by Sanofi-Aventis SA. Ketek has been associated with severe liver damage and death. In April 2004, Ketek was approved for upper respiratory infections in patients 18 years and older. The FDA had rejected the drug in 2001 and 2003, asking for more safety information. Although Sanofi's clinical...

• Fosamax: Bone-Density Drugs Can Kill Jaws

  Staff Writer | July 06, 2006 10:48 AM | 0 CommentsDenver, CO

  According to the Philadelphia Inquirer, dentists are asking patients whether they have used bone-density medications such as Fosamax before treatment or diagnosis. These drugs, known as bisphosphonates, are linking in numerous studies to a condition known as osteoncrosis of the jaw, or a rotting of the jawbone. Osteoncrosis is causing substantial injuries to victims that in some cases many cases...