On Monday, August 3rd, the Food and Drug Administration (FDA) approved the first 3D printed pill, signaling a new opportunity for drug makers and 3D printing technology.

Spritam, a medication for epilepsy, is manufactured by Ohio-based pharmaceutical company, Aprecia Pharmaceuticals.  This particular drug has already been on the market, but the new, 3D printed version, is designed to dissolve more rapidly than any other seizure medication.  This new design also allows for a high drug load to be delivered in a single dose, limiting the number of pills necessary.  The 3D printed design may be particularly helpful for children or other patients who have difficulty swallowing large pills.  By layering medication, 3D printing allows the creation of a more porous pill that can dissolve more quickly into liquid.  The pill should be available commercially early in 2016. 
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The FDA has issued new draft guidance that may make it easier for pharmaceutical companies to develop and market drugs to treat alcoholism.  The proposed guidance provides that the FDA may approve drugs that help patients improve their drinking behavior, even if the drugs do not help patients achieve complete sobriety.  The draft guidance is being issued consistent with FDA’s “good guidance practices” regulation (21 CFR 10.115) and will, when finalized, “represent the Agency’s current thinking on the development of drugs for the treatment of alcoholism and appropriate endpoints for clinical trials of drugs to treat alcoholism.”  The guidance “does not create or confer any rights for or on any person and does not operate to bind FDA or the public.”

For years, abstinence from any alcohol consumption has been the common goal of clinical trials to develop drugs to treat alcoholism.  According to the FDA, however, abstinence has been considered an “unattainable threshold” and “a hindrance to clinical development for drugs to treat alcoholism.”  The FDA’s new draft guidance, entitled Alcoholism:  Developing Drugs for Treatment Guidance for Industry, recognizes that other outcomes besides sobriety (called “surrogate endpoints”) may still be effective at treating alcoholism.  Thus, the draft guidance provides that drugs to treat alcoholism may be approved if they are clinically proven to help patients:


Continue Reading FDA Issues New Draft Guidance That May Ease Approval for Drugs to Treat Alcoholism

Last week, the New Jersey Appellate Division added more uncertainty and unpredictability in generic pharmaceutical litigation when it allowed some failure to warn claims to proceed against generic providers of metoclopramide, a/k/a Reglan in the case of  In re: Reglan Litigation.   Most of plaintiffs’ claims were dismissed, but the Court allowed a claim based on an alleged failure to update the generic label to match brand-name labels.  The generic manufacturers argued that they had in fact matched the brand name labels, but the Court found issues of fact existed that needed to be sorted out by a jury.  The Court did not, however, identify what any of those issues of fact were.
Continue Reading Generic Pharmaceutical Litigation Continues Amid Preemption Uncertainty