PLIVA, Inc. v. Mensing
Doctors prescribed both Gladys Mensing and Julie Demahy the drug Reglan. They each had their prescriptions filled with the generic equivalent of the name brand drug. After long-term use of this generic drug, Mensing and Demahy developed severe neurologic disorders. The women separately sued Pliva and Actavis, the generic drug manufacturers, making state law failure-to-warn claims, alleging that the drug’s warning label failed to adequately warn them of the risks. Pliva and Actavis argue that the federal Food, Drug, and Cosmetic Act, along with Food and Drug Administration regulations that govern the entire drug approval and labeling process, preempt Mensing and Demahy’s state law claims because it was impossible for Pliva and Actavis to comply with both federal and state law. The companies argue that they could not provide additional warnings beyond what the brand manufacturer provided on its label. In deciding this case, the Supreme Court will ultimately have to weigh the costs born by generic drug manufacturers and the public against the benefits of incentivizing manufacturers to create safer drugs with more complete warnings.
After taking metaclopramide for several years, both respondents developed tardive dyskinesia and sued the manufacturers of the medication that they took. The suits were based on failure-to-warn theories under state law. The defendant manufacturers in both cases argued that federal statutes and FDA regulations pre-empted respondents' state law claims by requiring generic manufacturers to provide the same labeling that was in use for the name-brand medication, Reglan®. The Fifth and Eighth Circuits both held that state law failure-to-warn claims against generic medication manufacturers were not preempted by federal law.
On June 23, 2011, in an ideologically divided ruling, the Supreme Court held, 5-4, that generic drug manufacturers may not be sued under state failure-to-warn laws because it would be “impossible” for the generic drug manufacturers to comply with both state law and federal law. The Supreme Court reversed. The Court held that "federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt," state-law claims for inadequate warnings. First, the Court reviewed the statutory framework governing generic medications and the Food and Drug Administration's interpretation of its regulations. The Court deferred to the FDA's interpretations (1) that generic labeling "must always be the same" as that of the name-brand medication so that the Changes Being Effected ("CBE") process was unavailable to generic manufacturers and (2) that the generic manufacturers could not have unilaterally issued "Dear Doctor" letters that provided additional warnings. The remaining issue was whether the state law requirements to provide warnings conflicted with the federal regulations that prevented the manufacturers from independently altering their warnings.
The rules for generic drugs are long and for it to be substituted for a brand name drug, it has to have the same active ingredients (the chemical substance that makes the drug work). It also has to have the same dosage strength, which is the volume of ingredients. It needs to be in the same physical form it was first in; for example if the original drug was in pill form it has to be the same. The way that the medication is put into the body also has to be the same. It has to deliver similar amounts of the drug to the bloodstream.
There are also many differences between generic and brand name drugs. Federal law requires that they look different; they could have different colors or shapes etc. They are also required to have different names and they may have differing inactive ingredients. Since drugs are made of inactive and active ingredients and some people may be sensitive to inactive ingredients like certain dyes used in drugs. Generic drugs cost between twenty and eight percent less than the brand name drug. The reason why brand name drugs cost so much more than generics is that it takes several years and many expenses with scientific development combined with clinical studies to get a drug approved to be on the market.
The manufacturers of new brand name drugs, which are also known as pioneer drugs usually, take on the research and development expenses for new drugs. The reason why the brand name drugs are so expensive in comparison is due to the research and development costs in addition to marketing. On the opposing end generic drugs don’t have to pay for the research since the original manufacturer has already done all the work to make sure that the drug is safe for people to take. The savings are then passed on to the consumer. But until the patent for the original drug is completed, no generics can be made. So if a drug has recently lost its patent then there won’t be that many generics on the market so the cost of the drug may still be high.
Reference:
132 S. Ct. 55; 180 L. Ed. 2d 924; 2011 U.S. LEXIS 5136; 80 U.S.L.W. 3078. LexisNexis Academic. Web. Date Accessed: 2013/11/08. 