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Category Archives: Generic Drugs

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Our Comment in Support of the FDA’s Proposed Rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985)

Posted in Generic Drugs, Preemption

Janice L. Weiner Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave. Bldg. 51, Room 6304 Silver Spring, MD 20993-0002   Dear Ms. Weiner, We are grateful for the opportunity to submit comments in support of the Food and Drug Administration’s (FDA) proposed rule entitled, Supplemental Applications Proposing Labeling Changes… Continue Reading

AAJ on Generic Preemption

Posted in FDA Regulation, Generic Drugs

Here’s a little more in-depth analysis of the generic drug argument before SCOTUS: Andre Mura, litigation counsel at the Center for Constitutional Litigation in Washington, D.C., said the government’s argument was troubling. “There were suggestions that the FDA shouldn’t be second-guessed, but as the Court said in Wyeth v. Levine, the FDA approval process does… Continue Reading

More coverage of generic drug liability

Posted in Generic Drugs

More on generic liability:   During a one-hour oral argument justices questioned whether federal law, in this case the requirement that generics have same design as the name-brand version, prevents plaintiffs from making such claims under state law.   Some justices signaled concern about juries making sweeping judgments about the effectiveness of drugs while others… Continue Reading

Sequester may or may not slow down approvals of generic drugs

Posted in Generic Drugs, Politics

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

Will consumers once again be able to sue generic drug manufacturers?

Posted in Generic Drugs, Preemption

Longtime readers of this (or any drug-related blog) know that the U.S. Supreme Court ruled that manufacturers of generic drugs cannot be sued for failure-to-warn claims.  The ruling created a legal injustice for those injured by generic drugs. While every plaintiff’s lawyer has secretly hoped that Congress would fix the law, we’re all savvy enough… Continue Reading

SSRI Use during Pregnancy Raises Risk of Serious Birth Defects

Posted in Generic Drugs, Paxil Birth Defects, Prozac Birth Defects, Zoloft Birth Defects

In a study published in a 2007 edition of the New England Journal of Medicine, Sura Alwan et al. evaluates the effect of maternal use of selective serotonin reuptake inhibitor medications (SSRIs) during pregnancy on the likelihood of bearing children with congenital malformations.  The study, titled “Use of Selective Serotonin Reuptake Inhibitors in Pregnancy and the… Continue Reading

Supreme Court To Decide Generic Drug Preemption Issue After All

Posted in Generic Drugs

I’ve been engrossed in a mesothelioma trial and have fallen behind in blogging. Frequent readers will snarkily note that this is not an uncommon occurrence. However, there has been a major development in generic pharmaceutical litigation. The Supreme Court has granted certiorari (that means accepted) in three Reglan lawsuits. If the Supreme Court rules in… Continue Reading

Pay-to-Delay Is Still OK

Posted in Generic Drugs

A common but unfounded criticism of product liability lawyers is that they keep needed drugs off the market.  Actually, it’s the drug companies who do so by engaging in pay-to-delay.  Here’s how that works: Big pharmaceutical companies pay generic manufacturers not to sell generic versions of brand-name drugs.  And unfortunately, this practice has now been… Continue Reading

Enading Pay-to-Delay deals will save taxpayers billions of dollars… and may save some lives, too.

Posted in Generic Drugs, Politics

Pay-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

Brand-name Pharmaceuticals Again Block Generics

Posted in Generic Drugs

Remember, one of the common arguments of the tort reform crowd is that trial lawyers keep drugs from coming to market.  If pharmaceuticals were really concerned about people having access to drugs, would they be doing this? WASHINGTON—The Federal Trade Commission expressed concern about the practices of brand-name drug makers after generic drug companies complained… Continue Reading

Tar Heel Students Protest Healthcare Reforms That May Raise The Cost of Generic Drugs

Posted in Generic Drugs

Sounds like a group of well-informed students: You’ve seen on television the shouting and angry protesting at town hall meetings across America. Most, if not all, are about the proposed healthcare reforms that are being considered in Congress. At the University of North Carolina, the issue is a hot topic, too. And the students concerned… Continue Reading

Are there hidden dangers to using generic drugs?

Posted in Generic Drugs

In theory, no.  Generic drugs are supposed to be just as safe and effective as brand-name drugs.  However, there is some evidence that they may not be: “The average citizen would want to know that someone is checking that manufacturers are making the drugs they got approval to make,” says William K. Hubbard of Chapel… Continue Reading