- Chinese Death Star: The moon cited as the perfect launch pad for ballistic missiles
- Help wanted: Homeland Security plagued by vacancies at the top
- We are not amused: Queen’s protection officers warned to keep ‘sticky fingers’ off the royal cashews
- Unleash the crossbows: Gov. Scott Walker creates new hunting season
- Bubonic plague kills 20 in Madagascar
- G-20 diplomats fell for hacker attack promising nude photos of former French first lady Carla Bruni
- Minnesota guardsman charged with stealing private soldier data for fake IDs
- Florida appeals court rules universities can’t regulate guns
- Vladimir Putin defends Russian conservative values
- Tea Party Patriots call key GOP firing a declaration of war
US probes Sanofi over blockbuster drug Plavix
Question of the Day
PARIS (AP) - The U.S. Justice Department is investigating drug maker Sanofi's disclosures to the Food and Drug Administration about different responses to its blockbuster blood thinner Plavix.
The French company said in a filing with the Securities and Exchange Commission last week that it learned in June about the investigation.
It did not provide details, saying only that the investigation centered on "the variability of response to Plavix." The company did not immediately respond to requests to give more details on the investigation.
Plavix is prescribed to heart disease patients to prevent dangerous blood clots, which can cause heart attack, stroke and death. In 2010, the FDA added a black box _ its strongest form of warning _ to the drug's label. At the time, the watchdog said certain patients with a genetic variation cannot metabolize the drug, putting them at increased risk for heart attack and stroke.
Before it got U.S. generic competition last May, Plavix was the No. 2 drug in the world by revenue, with annual sales of around $9 billion in 2011.
Sanofi says it is cooperating with the investigation into Plavix, which is jointly marketed with U.S.-based Bristol-Myers Squibb. Bristol-Myers Squibb spokeswoman Jennifer Fron Mauer said the company had no comment on the investigation.
Experts were divided over the potential impact of the investigations, partly because few details are known.
"If the company knew about it in June, why did it delay disclosure?" said Erik Gordon, professor and analyst at University of Michigan's Ross School of Business. "Investors are likely to bring lawsuits over the delay."
He noted that the DoJ's involvement raised the stakes: "The DoJ has people who carry badges. It can pursue criminal penalties. It could indicate that the FDA thinks the companies deliberately misled the agency. "
But Les Funtleyder, healthcare strategist at private equity fund Poliwogg, said the probe was likely not a big deal as it is retrospective.
"These issues seem to crop up a lot with pharmaceuticals," he said. "This is the type of event that investors tend to look around, as the occurrence is fairly common."
Shares in Sanofi ended the day 0.5 percent lower on Monday, slightly worse than the broader market.
In order to work effectively, Plavix must be broken down by a particular liver enzyme. But the FDA says 2 to 14 percent of people in the U.S. have low levels of the enzyme, preventing them from successfully processing Plavix. The likelihood of being a non-responder varies by race, according to the FDA.
AP Business Writer Linda A. Johnson in Trenton, N.J., contributed to this story.
By Matt Kibbe
The short-term deal will assure long-term overspending
- Obama's Afghanistan experts stumped on U.S. death toll, war costs during hearing
- NAPOLITANO: A conspiracy so vast
- House pushes through two-year Ryan-Murray budget deal
- Comma on!: Twitter erupts over Obama-Castro 'marriage'
- N. Korean news agency: Kim Jong Un's uncle executed
- Biden guarantees victory on immigration reform
- Jane Fonda Foundation fails to make single contribution in 5 years: report
- All-out war breaks out in GOP over budget pact
- U.S. pilot scares off Iranians with 'Top Gun'-worthy stunt: 'You really ought to go home'
- White House improvises again on patchy Obamacare rollout
Independent voices from the The Washington Times Communities
Born in 1930 in rural Missouri, Charles Vandegriffe, Sr., brings his time and place to the Communities.
Columns from Voices around the World talking about the events, people, politics and social issues that concern us wherever, and whoever, we are.
Chef Mary Moran discusses the food we eat, where it comes from and what it does for us.
An informed and often humorous take on the world of advertising, public relations and social media. 100% Pure. Not from concentrate.
Extraordinary day at Redskins Park
White House pets gone wild!
Let it snow