Supreme Court rules in favor of drug companies, FDA in case involving Philly's Mutual Pharmaceutical Co.
In a case involving Philadelphia's Mutual Pharmaceutical Co., a divided U.S. Supreme Court ruled Monday that federal law related to pharmaceutical regulations preempts a person's ability to sue in state courts and allege that a generic drug is designed badly.
The 5-4 decision - split along the traditional conservative-liberal line - is a victory for the drug industry and, indirectly, the U.S. Food and Drug Administration.
The case is Mutual Pharmaceutical Co., v. Bartlett, 12-142.
A Senate committee is scheduled to meet Monday afternoon to discuss problems of questionable prescribing practices under the Medicare Part D program. A recent report found that more than 700 doctors had unusually high prescribing patterns, and more half of them tended to scribble scripts for controlled substances.
Part D is the prescription drug portion of Medicare, the federal government's insurance program for people age 65 and older, along with some younger people who are disabled. Taxes pay for Medicare, generally. However, when President Bush pushed through Medicare Part D - which cost the federal government $62 billion in 2012 - he did not push through extra taxes to pay for it.
Not surprisingly, seniors like discounted medication.
The Food and Drug Administration said it has approved Teva's Plan B One-Step for all ages without a prescription, which represents another step in the decade long legal and regulatory debate over access to emergency oral contraception, often referred to as the morning-after pill.
New York Federal Judge Edward Korman - and briefly, so far, the U.S. Court of Appeals for the Second Circuit - has been officiating the legal arguments between the federal government and groups seeking greater access to the medicine for women of all ages and at the lowest possible price.
Teva Pharmaceutical Industries, Ltd., is based in Israel but has its Americas headquarters in Montgomery County, outside Philadelphia, makes Plan B One-Step.
The U.S. Supreme Court issued three decisions Thursday, but none of them were Mutual Pharmaceutical Co., v. Bartlett, 12-142.
Mutual used to be a private, stand-alone Philadelphia company, founded in 1947. But since the case began, it was sold to Takeda Pharmaceuticals and then Sun Pharmaceuticals, so Sun inherits the ligation. The case involves whether federal law regarding FDA rules supersede a patient's ability to sue a generic drug company for product design in state court. A New Hampshire woman, Karen Bartlett, suffered a horrible reaction to a generic drug made by Mutual.
A previous Inquirer story, in advance of oral arguments, is here.
Johnson & Johnson's McNeil Consumer Healthcare unit has had dozens of recalls in the last few years and the plant in the Philadelphia suburb of Fort Washington has been closed since April 2010. (Other units and divisions have had similar issues.)
In a brief interview Wednesday after speaking at the Wharton Leadership Conference at the University of Pennsylvania, J&J chief executive officer Alex Gorsky said the company was waiting for the FDA to "check off" some of the boxes on the list of repairs or renovations that J&J had to complete before a full review is done, perhaps by the end of 2013.
Thursday's Inquirer print story is here.
When drugmaker Teva bought Frazer-based Cephalon in 2011, it got brand-name drugs in hopes of further diversifying its business and making it less dependent on revenue from generic drug sales.
But Teva also got Cephalon litigation and investigations, including lawsuits directly impacted by Monday's Supreme Court decision involving so-called pay-to-delay deals or reverse payments.
Last July, Judge Mitchell Goldberg of the federal District Court in Philadelphia put on hold a lawsuit filed by the Federal Trade Commission against Cephalon.
Congressman Henry Waxman, one of the fathers of the 1984 law that greatly increased the use of generic drugs in the United States, applauded Monday's Supreme Court decision that shook the pharmaceutical industry.
The Supreme Court upended a big part of the relationship between generic and brand-name drug companies on Monday by siding with the Federal Trade Commission in FTC v. Actavis, et. al., in the so-called pay-to-delay case. Basically, the court said that if brand-name companies pay generic competitors to delay trying to introduce cheaper generic versions of drugs, such arrangements can be subject to antitrust laws.
The Supreme Court decided 5-3 on the decision, with Justice Stephen Breyer writing the opinion for the majority, which included Anthony Kennedy, Elena Kagan, Sonia Sotomayor and Ruth Bader Ginsburg. The dissent was written by Chief Justice John Roberts, who was joined by Justices Antonin Scalia and Clarence Thomas. Justice Samuel Alito recused himself from the case.
Drugmaker Merck is laying off an unspecified number of managers as it tries to cut costs and get more from its research and development unit, Merck Research Laboratories.
"MRL’s organizational structure has been altered to simplify governance so that Merck can advance therapeutic and vaccine candidates more efficiently and focus resources on its most promising programs," Merck spokesman Steve Cragle said in an email. "The new design has been established to ensure that MRL leaders have the authority to take appropriate actions to facilitate rapid pipeline progress. It is too early to provide numbers or comment on any individuals that may or may not be affected by these changes."
Like many drug companies, Merck is searching for new drugs to replace highly profitable medicines that lost patent protection and now face generic competition. The asthma drug Singulair is one example. Also like the other drugmakers, Merck facing price pressure from insurers, public and private, especially in Europe.