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  • Supreme Court Again Rules in Favor of Generic Pharmaceutical Industry, Supports Federal Preemption

    The current term of the US Supreme Court has already been a momentous one for the life sciences industry, having declared patents on naturally-occurring DNA invalid and legal settlement agreements commonly known as "pay for delay" agreements potentially illegal under federal competition law. Now the court has released a third potentially landmark decision, Mutual Pharmaceutical Co. v. Bartlett , in which the justices have decided that when it comes to so-called "failur...
  • BREAKING: Supreme Court Rules Naturally Occurring DNA is Not Patentable

    In a landmark decision, the Supreme Court has decided in favor of the Association for Molecular Pathology in its case against Myriad Genetics, ruling that naturally occurring DNA is not patentable, while synthetic DNA is. Background The case, heard in April 2013, concerned patents held on two genes, BRCA 1 and BRCA2, which are closely linked to a woman's risk of breast and ovarian cancer. Myriad Genetics, a biotechnology company, owned the patent rights to the use of th...
  • Preview: Supreme Court Could Determine Biotechnology Industry's Future

    Depending upon whom you ask, a case to be heard by the US Supreme Court on Monday will either mark a massive blow to the biotechnology industry and its regulated products or a massive blow to the practice of science, including the ability to use a genetic marker to determine the best course of treatment for a patient. Regardless of the veracity of either side's claim, one thing is clear: the case of Association for Molecular Pathology, et al vs. Myriad Genetics will be ...
  • In Landmark Ruling, Court Sees Off-Label Marketing as Protected Free Speech

    • 04 December 2012
    In a potentially landmark ruling, the US 2 nd Circuit Court of Appeals has reversed a lower court's finding that a pharmaceutical sales representative was guilty of promoting off-label uses for certain approved drug products, finding that the government's actions had violation the man's right to free speech. Many analysts questioned whether the ruling could eventually lead to a sea change in the way drug promotion is conducted in the US. Currently, companies are not a...
  • Stem Cell Processor, IRB Targets of Related Warning Letters from FDA

    The US Food and Drug Administration (FDA) is continuing to enforce a controversial policy involving the regulation of stem cell therapies, which the agency defends as enforcing established authority but critics have derided as the regulation of the practice of medicine. A 24 September warning letter to Texas-based CellTex Therapeutics Corporation references the firm's use of adipose tissue (lipoaspirate) recovered from donors, which is then isolated and cultured into adi...
  • FTC Seeks Supreme Court's Intervention in 'Pay-for-Delay' Cases

    The US Federal Trade Commission (FTC) is calling on the US Supreme Court to review a so-called "pay-for-delay" case concerning generic and branded versions of AndroGel , a topical testosterone treatment, a new escalation in the agency's long-standing efforts to curb the practice. Pay-for-delay cases involve the manufacturer of a patented, innovative medicine paying its potential competitors not to manufacture generic versions of that medicine. FTC has consistently attac...
  • Study: Regulatory Noncompliance Plays Big Role in Record-Setting Fines

    Regulatory compliance woes have contributed to record-setting fines paid by pharmaceutical companies since 1991-more than $30 billion in total -- claims a new report published by the health advocacy group Public Citizen. The report, " Pharmaceutical industry Criminal and Civil Penalties: an Update ," follows an earlier 2012 report by the same group in which it found that nearly $20 billion had been recovered by federal officials from pharmaceutical companies since 1991, ...
  • FDA Debars Two for Falsifying Clinical Trial Data

    Federal regulators have debarred two researchers formerly employed by Kansas-based Lee Research Institute for falsifying data obtained from a clinical trial conducted on behalf of Schering-Plough, now a subsidiary of Merck & Co. The researchers, Lisa Jean Sharp and Wayne Spencer , were both convicted in march 2012 of felony counts of failing to prepare and maintain records required under the Federal Food, Drug and Cosmetic Act (FD&C Act) with the intent to d...
  • In Ruling Against KV Pharmaceuticals, FDA's Enforcement Discretion Upheld

    A lawsuit filed by KV Pharmaceuticals against the US Food and Drug Administration (FDA) was thrown out of court on 6 September 2012 after a judge ruled the company could not challenge activities falling under FDA's enforcement discretion. KV filed its suit against FDA in July 2012 over FDA's allowance of compounded versions of its anti-premature pregnancy drug Makena (17P / hydroxyprogesterone caproate injection) to remain on the market. A Long-Running Saga The long...
  • Former FDA Official Slams Regulation of Stem Cells as Exceeding Agency Authority

    Should the US Food and Drug Administration (FDA) have the authority to regulate cells derived from-and later put back into-a person? A recent opinion-editorial published in The Wall Street Journal by former FDA Associate Commissioner Scott Gottlieb and Coleen Klasmeier , head of FDA practice at the law firm Sidley Austin LLP, argues FDA's efforts to increase regulatory enforcement against stem cell manufacturers has the potential to backfire against the nascent an...
  • Pfizer Settles With SEC Over Charges it Bribed Foreign Regulatory Officials

    Pharmaceutical manufacturing giant Pfizer has settled corruption charges leveled against it by the Securities and Exchange Commission (SEC) and the Department of Justice (DOJ), both of which said the company had violated the Foreign Corrupt Practices Act (FCPA) by bribing foreign officials to win business and allow its products to access markets. SEC said in a statement the company and its agents had bribed officials in Bulgaria, China, Croatia, the Czech Republic, I...
  • Responsible Corporate Officer Doctrine Upheld by Appeals Court

    • 30 July 2012
    The US Circuit Court of Appeals for Washington, DC, has ruled in favor of an emerging enforcement technique used by the federal government to bar individuals from certain employment opportunities after being found guilty of defrauding programs such as Medicare and Medicaid. The technique could be of enormous consequence for the pharmaceutical and medical device industries, both of which do large amounts of business through Medicare, Medicaid, Tricare and numerous other g...