Drug & Device News

Eleventh Circuit to Decide if University May Grow Marijuana for Research Purposes

Professor Lyle Craker of the University of Massachusetts-Amherst Department of Plant, Soil and Insect Sciences has appealed a Drug Enforcement Administration (DEA) decision denying his bid to grow marijuana for medical research. Currently, the only facility in the United States legally authorized to grow marijuana for such purposes is located at the University of Mississippi. The U.S. Court of Appeals for the First Circuit heard oral arguments in May. The case, Craker v. DEA, began with Craker's written request to the DEA for a license to grow marijuana because “[a] second source of plant material is needed to facilitate privately funded, FDA-approved research into medical uses of marijuana, ensuring a choice of sources and an adequate supply of quality, research-grade marijuana for medicinal applications.” In its 2009 denial order, DEA administrator Michele Leonhart wrote that Craker's proposed registration was inconsistent with the United States' obligations under the U.N. Single Convention on Narcotic Drugs, because that convention requires a monopoly on the wholesale distribution of research-grade marijuana in the United States. Leonhart's order also explained that Craker had failed to make a showing that the supply of medical-grade marijuana from the University of Mississippi was inadequate for U.S. research purposes.

Market Exclusivity Remains Elusive for Makena

After KV Pharmaceuticals received approval in February 2011 to market Makena (hydroxyprogesterone caproate), a drug designed to reduce the risk of preterm births in women who have suffered one such birth previously, the company expected it could market the drug on an exclusive basis for several years. However, pharmacists had for years been using the active ingredient in Makena to compound their own, unapproved, versions of the drug, which typically sell for $15 to $20 per one-week dose. There was a backlash when KV Pharmaceuticals disclosed it would charge about a hundred times that amount for its brand-name product, prompting the FDA to permit pharmacists to continue selling their compounded products, despite the fact that an FDA-approved version was now available.

KV Pharmaceuticals responded some months later by providing the FDA with compounded versions of Makena that it alleged should raise concerns in the agency about these products' efficacy and purity. On June 15, the FDA issued its findings: The compounded products were, by and large, as potent and as pure as they should be. The agency stated, “Although the analysis of this limited sample of compounded hydroxyprogesterone caproate products ' did not identify any major safety problems, approved drug products, such as Makena, provide a greater assurance of safety and effectiveness than do compounded products.” But it went on to say that it would continue to permit pharmacist-made Makena substitutes to be sold, so long as they continue to contain pure and effective ingredients that pose no danger to the public.

Flonase Monopoly Plaintiff Class Is Certified

U.S. District Judge Anita Brody of the Eastern District of Pennsylvania has certified a class of third-party purchasers ' primarily union-affiliated health plans' that claim pharmaceuticals manufacturer GlaxoSmithKline (GSK) improperly filed citizen petitions with the FDA in order to keep generic versions of its nasal spray Flonase out of the marketplace. In its peak year, the drug accounted for more than $1.3 billion in sales for the company, but GSK's patent on Flonase expired in 2003, opening the way for generic manufacturers to enter the market. However, until 2007 when the law was changed, the FDA was required to respond to any citizen petition challenging market approval of a drug. The plaintiffs allege that by filing “several frivolous citizen petitions,” GSK interfered with the FDA's review process and successfully kept generic versions of Flonase out of the marketplace until 2006. The named plaintiffs are all residents of Arizona, Florida, Massachusetts and Wisconsin, and their claims of monopolization, unfair and deceptive trade practices, and unjust enrichment will be decided based on the laws of the states where they purchased Flonase.

Oxygen Aids Recalled over Fire Danger

The FDA has classified Nidek Medical Products Inc.'s voluntary recall of its Medical Mark5 Nuvo Lite Oxygen concentrators numbered in the range of 042-10000 through 102-09335 as a Class I recall. Some of the affected devices, all manufactured and distributed between January 2004 and May 2010, have experienced capacitor-related fires, causing not only fire danger, but also loss of needed supplemental oxygen.

Texas Adopts Learned Intermediary Rule

With its June decision in Centocor Inc. v. Patricia and Thomas Hamilton, the Supreme Court of Texas brought that state in line with the majority of states by holding that the learned intermediary doctrine applies when a doctor prescribes a medication to a patient. The plaintiff had prevailed at trial on her claim that she contracted a lupus-like disease after using Remicade to treat her Crohn's disease, and that its manufacturer was at fault for failing to warn her of this possiblility. An intermediate appeals court affirmed, ruling that the learned intermediary rule does not apply when a drug manufacturer advertises its product directly to the public. In reversing, Texas' Supreme Court noted that, “[u]ntil now, we have not considered a case that squarely presents the applicability of the learned intermediary doctrine within the context of prescription drug products-liability cases.” With this case before it, the high court held that “a prescription drug manufacturer fulfills its duty to warn end users of its product's risks by providing adequate warnings to the intermediaries who prescribe the drug and, once fulfilled, it has no further duty to warn the end users directly.”

DOJ Announces Largest Drug Fraud Settlement in U.S. History

On July 2, Deputy Attorney General James Cole made the announcement that the U.S. Department of Justice (DOJ) had settled a civil and criminal matter with pharmaceuticals manufacturer GlaxoSmithKline (GSK) for the enormous sum of $3 billion. The government had charged the company with promoting its drug Paxil for the treatment of depression in children under 18 years old, despite its not having been approved for that population. GSK was also accused of promoting the depression treatment drug Wellbutrin for several unapproved purposes, including weight loss and sexual dysfunction. Finally, GSK agreed to plead guilty to one count of failing to report safety data about the drug Avandia to the FDA. “Today's multi-billion dollar settlement is unprecedented in both size and scope. It underscores the Administration's firm commitment to protecting the American people and holding accountable those who commit health care fraud,” said Cole in a statement. “At every level, we are determined to stop practices that jeopardize patients' health, harm taxpayers, and violate the public trust ' and this historic action is a clear warning to any company that chooses to break the law.”

Eleventh Circuit to Decide if University May Grow Marijuana for Research Purposes

Professor Lyle Craker of the University of Massachusetts-Amherst Department of Plant, Soil and Insect Sciences has appealed a Drug Enforcement Administration (DEA) decision denying his bid to grow marijuana for medical research. Currently, the only facility in the United States legally authorized to grow marijuana for such purposes is located at the University of Mississippi. The U.S. Court of Appeals for the First Circuit heard oral arguments in May. The case, Craker v. DEA, began with Craker's written request to the DEA for a license to grow marijuana because “[a] second source of plant material is needed to facilitate privately funded, FDA-approved research into medical uses of marijuana, ensuring a choice of sources and an adequate supply of quality, research-grade marijuana for medicinal applications.” In its 2009 denial order, DEA administrator Michele Leonhart wrote that Craker's proposed registration was inconsistent with the United States' obligations under the U.N. Single Convention on Narcotic Drugs, because that convention requires a monopoly on the wholesale distribution of research-grade marijuana in the United States. Leonhart's order also explained that Craker had failed to make a showing that the supply of medical-grade marijuana from the University of Mississippi was inadequate for U.S. research purposes.

Market Exclusivity Remains Elusive for Makena

After KV Pharmaceuticals received approval in February 2011 to market Makena (hydroxyprogesterone caproate), a drug designed to reduce the risk of preterm births in women who have suffered one such birth previously, the company expected it could market the drug on an exclusive basis for several years. However, pharmacists had for years been using the active ingredient in Makena to compound their own, unapproved, versions of the drug, which typically sell for $15 to $20 per one-week dose. There was a backlash when KV Pharmaceuticals disclosed it would charge about a hundred times that amount for its brand-name product, prompting the FDA to permit pharmacists to continue selling their compounded products, despite the fact that an FDA-approved version was now available.

KV Pharmaceuticals responded some months later by providing the FDA with compounded versions of Makena that it alleged should raise concerns in the agency about these products' efficacy and purity. On June 15, the FDA issued its findings: The compounded products were, by and large, as potent and as pure as they should be. The agency stated, “Although the analysis of this limited sample of compounded hydroxyprogesterone caproate products ' did not identify any major safety problems, approved drug products, such as Makena, provide a greater assurance of safety and effectiveness than do compounded products.” But it went on to say that it would continue to permit pharmacist-made Makena substitutes to be sold, so long as they continue to contain pure and effective ingredients that pose no danger to the public.

Flonase Monopoly Plaintiff Class Is Certified

U.S. District Judge Anita Brody of the Eastern District of Pennsylvania has certified a class of third-party purchasers ' primarily union-affiliated health plans' that claim pharmaceuticals manufacturer GlaxoSmithKline (GSK) improperly filed citizen petitions with the FDA in order to keep generic versions of its nasal spray Flonase out of the marketplace. In its peak year, the drug accounted for more than $1.3 billion in sales for the company, but GSK's patent on Flonase expired in 2003, opening the way for generic manufacturers to enter the market. However, until 2007 when the law was changed, the FDA was required to respond to any citizen petition challenging market approval of a drug. The plaintiffs allege that by filing “several frivolous citizen petitions,” GSK interfered with the FDA's review process and successfully kept generic versions of Flonase out of the marketplace until 2006. The named plaintiffs are all residents of Arizona, Florida, Massachusetts and Wisconsin, and their claims of monopolization, unfair and deceptive trade practices, and unjust enrichment will be decided based on the laws of the states where they purchased Flonase.

Oxygen Aids Recalled over Fire Danger

The FDA has classified Nidek Medical Products Inc.'s voluntary recall of its Medical Mark5 Nuvo Lite Oxygen concentrators numbered in the range of 042-10000 through 102-09335 as a Class I recall. Some of the affected devices, all manufactured and distributed between January 2004 and May 2010, have experienced capacitor-related fires, causing not only fire danger, but also loss of needed supplemental oxygen.

Texas Adopts Learned Intermediary Rule

With its June decision in Centocor Inc. v. Patricia and Thomas Hamilton, the Supreme Court of Texas brought that state in line with the majority of states by holding that the learned intermediary doctrine applies when a doctor prescribes a medication to a patient. The plaintiff had prevailed at trial on her claim that she contracted a lupus-like disease after using Remicade to treat her Crohn's disease, and that its manufacturer was at fault for failing to warn her of this possiblility. An intermediate appeals court affirmed, ruling that the learned intermediary rule does not apply when a drug manufacturer advertises its product directly to the public. In reversing, Texas' Supreme Court noted that, “[u]ntil now, we have not considered a case that squarely presents the applicability of the learned intermediary doctrine within the context of prescription drug products-liability cases.” With this case before it, the high court held that “a prescription drug manufacturer fulfills its duty to warn end users of its product's risks by providing adequate warnings to the intermediaries who prescribe the drug and, once fulfilled, it has no further duty to warn the end users directly.”

DOJ Announces Largest Drug Fraud Settlement in U.S. History

On July 2, Deputy Attorney General James Cole made the announcement that the U.S. Department of Justice (DOJ) had settled a civil and criminal matter with pharmaceuticals manufacturer GlaxoSmithKline (GSK) for the enormous sum of $3 billion. The government had charged the company with promoting its drug Paxil for the treatment of depression in children under 18 years old, despite its not having been approved for that population. GSK was also accused of promoting the depression treatment drug Wellbutrin for several unapproved purposes, including weight loss and sexual dysfunction. Finally, GSK agreed to plead guilty to one count of failing to report safety data about the drug Avandia to the FDA. “Today's multi-billion dollar settlement is unprecedented in both size and scope. It underscores the Administration's firm commitment to protecting the American people and holding accountable those who commit health care fraud,” said Cole in a statement. “At every level, we are determined to stop practices that jeopardize patients' health, harm taxpayers, and violate the public trust ' and this historic action is a clear warning to any company that chooses to break the law.”