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generic drugs 20 articles

AL Supreme Court rules: Brand name drug makers liable for warnings on generic drug counterparts

Makers of brand-name medications can be held liable for warnings on generic drugs even if the generic was produced by another drug company, the Alabama Supreme Court ruled. A majority of the nine-member court upheld a 2013 decision, which was viewed as a defeat by business leaders in this mostly Republican state. The ruling is based on a federal lawsuit filed by Danny and Vick Weeks against five current and former drug makers alleging that long-term use of the heartburn drug metoclopramide, which was also sold under the brand name Reglan, caused a debilitating movement disorder known as tardive dyskinesia. ... Read More

FDA chief fields tough questions about proposed new labeling rule for generic drug makers

Food and Drug Administration (FDA) commissioner Margaret Hamburg last week fielded tough questions from a Congressional committee regarding a controversial proposed rule that would allow generic drug makers to update their warning labels beyond what the brand name lists on its safety label, a move that would ignite a bevvy of personal injury lawsuits. Currently, drug companies are required to bear the same safety labels on their generic drugs as their branded counterparts. Manufacturers of generic drugs cannot by law independently update their labels if the company becomes aware of new information about the drug, nor can they be held ... Read More

FDA creates new unit to address quality concerns with drugs made overseas

Concerns about drug quality have prompted the Food and Drug Administration (FDA) to create a new unit in order to improve the agency’s scrutiny of overseas drug manufacturing plants producing brand-name, generic and over-the-counter drugs of questionable quality. The Office of Pharmaceutical Quality aims to work with drug makers to develop data that can help identify which manufacturing plants are falling below standards and need closer and more frequent inspection. Such information is currently only collected during regular inspections. The goal is to head off any issues that would result in penalties, such as banning a product for sale in the United ... Read More

Collaborative generic drug inspections initiative launched by FDA and European Medicines Agency

A joint initiative was launched Dec. 18 by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to share information on examinations of bioequivalence studies in support of generic drug approvals. The agencies will work in a collaborative effort, providing a mechanism to conduct joint facility inspections for generic drug applications. A generic drug must undergo studies submitted through generic drug applications demonstrating that the drug is “bioequivalent,” meaning that the generic drug must behave in the same manner as the brand-name drug. In order to ensure that the data submitted to the agencies is reliable, ... Read More

FDA new rule would make generic drug companies accountable for safety of their drugs

The Food and Drug Administration (FDA) is seeking a new rule to close a loophole that prevents manufacturers of generic drugs from adequately warning patients of potentially harmful side effects, and the public is encouraged to weigh in on the plan. About 80 percent of all prescription drugs sold today are generic versions of brand-name drugs. Generics are required to bear the same safety labels as their branded counterparts. However, manufacturers of generic drugs cannot by law independently update their labels if the company becomes aware of new information about the drug, nor can they be held accountable if their ... Read More

FDA proposes new rule to allow generic drug makers ability to update safety labels

The Food and Drug Administration (FDA) is taking steps to allow manufacturers of generic drugs permission to change safety labels when new information about potential side effects is discovered. Currently, generic drug makers are required to have the same safety labels as their brand-name counterpart. For years, citizen groups have petitioned the FDA to take measures to ease the regulations that prevent generic drug companies from providing new information about potential risks associated with their products. Brand-name drugs go through a rigorous approval process through the FDA during which they must provide data from clinical trials demonstrating the drug’s safety ... Read More

Supreme Court: patients cannot sue generic drug makers for inappropriate warning labels

Makers of generic drugs cannot be sued by patients who experience side effects if the warning label on the drugs is the same as those on the brand-name product, the U.S. Supreme Court ruled. The ruling preempts state laws that require pharmaceutical companies to provide patients with updated information regarding adverse events. The federal law could be detrimental to consumers, preventing them from suing generic drug companies regardless of the severity of their injuries. However, consumers of brand-name drugs can still file suit against the brand-name drug makers. The catch is that most insurance companies require patients to use a ... Read More

Generic drug maker settles whistleblower case for $500 million

MONTGOMERY, Ala.—The Alabama Attorney General’s office announced Tuesday that it participated with other states and the federal government in a $500-million settlement with India-based generic drug manufacturer Ranbaxy to resolve civil and criminal allegations that company for years made and sold dozens of adulterated prescription drugs. The company’s willful manufacture of 26 generic prescription drugs below the U.S. Food and Drug Administration’s (FDA) standards for strength, purity, and quality resulted in fraudulent claims submitted to Alabama’s Medicaid Agency as well as other state and federal health care programs. “This settlement sends a strong message to international drug manufacturers that they ... Read More

Supreme Court considers legality of drug companies’ pay-for-delay deals

An attorney for the Federal Trade Commission (FTC) urged the Supreme Court to stop so-called pay-for-delay deals among pharmaceutical companies that keep generic drugs off the market longer and keep costs to consumers high. “It’s unlawful to buy off the competition,” said Malcolm Stewart, an attorney for the FTC and the Justice Department, arguing that the practice among drug companies is “presumptively illegal.” The hearing will determine whether there is a violation of antitrust laws when brand name drug companies pay generic drug makers of the same drug to postpone launch of their products. New brand-name drugs to hit the market ... Read More

Alabama court rules that makers of brand name drugs can be sued by generic drug users

Generic drugs should carry the same warnings as the brand name drug and, if not, then users of the generic drug can sue the name-brand drug maker for fraudulent misrepresentation, the Alabama Supreme Court ruled. The ruling comes as a response to a certified question from a U.S. District Court, which arose during a case where a plaintiff alleged that a generic version of the prescription heartburn drug Reglan caused him to develop a movement disorder called Tardive Dyskinesia. The plaintiff sued the brand name maker, Wyeth, alleging that the company failed to warn both doctors and patients of the ... Read More