• 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...
  • US Court: Stem Cells may be Regulated as Drugs

    • 27 July 2012
    The US District Court in Washington, DC, has ruled that the US Food and Drug Administration (FDA) may legally regulate stem cell therapies as drug products-an opening salvo in what is likely to be a lengthy court battle between the agency and a company accused of violating federal regulations. The entire case results from a 2008 enforcement activity by FDA in which it found Colorado-based Regenerative Sciences to be in violation of federal law. In a 2008 warning let...
  • Court Orders FDA to Release Thousands of Documents on Surveillance Program

    The US Food and Drug Administration (FDA) has been ordered by a federal judge to release thousands of documents to an attorney representing former employees of the agency who now allege they were the subject of an illegal surveillance program. Judge James Boasberg of the District Court of DC sided with the National Whistleblowers Center (NWC) at the 23 July hearing, and has ordered the agency to turn over more than 4,000 pages of documents related to the case to NWC by...
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    Orange Book Listings Lesson: An overly broad use code may lead to legal challenges

    The US court system has been busy recently with issues affecting the pharmaceutical industry, including a number of cases involving the Hatch-Waxman Act. On 17 April 2012, the Supreme Court issued a unanimous decision in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S marking the first Abbreviated New Drug Application (ANDA) case decided by the high court since the passage of the act in 1984. The Supreme Court has a long history of overturning Federal C...
  • Court: 'Pay-for-Delay' Practice Anticompetitive, Illegal

    In a potentially precedent-setting decision, a federal court has declared that payments made by companies to delay generic competition-also known as pay-for-delay settlements-are anti-competitive and illegal. The lawsuit, filed in the Third Circuit Court of Appeals in California, involved some of the pharmacy and pharmaceutical industry's largest companies, including CVS Pharmacy, Rite Aid, Walgreen, and Merck. The case was also supported by the Federal Trade Commissio...