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Congress has questions for J&J, FDA
July 2011
by Amy Swinderman  |  Email the author


WASHINGTON, D.C.—Following a series of recent product recalls by Johnson & Johnson (J&J), a United States Congressman has voiced concerns that the U.S. Food and Drug Administration (FDA) lacks sufficient oversight of the pharma giant's operations in Puerto Rico.
According to Rep. Darrell Issa, R-Calif., the FDA's failure to monitor J&J's manufacturing problems in Puerto Rico is "deeply troubling," and as chairman of the House Committee on Oversight and Government Reform, he detailed his concerns in a recent letter to FDA Commissioner Margaret Hamburg.
In fact, in recent months, Issa has accused the FDA of being "too cozy" with J&J, particularly after J&J removed Motrin from stores in 2009 without announcing a formal recall. Under current law, the FDA does not have the authority to force a company to recall a product, regardless of the threat to public health. No serious injuries or deaths have been tied to the recalled painkiller, but J&J said the affected pills contained lesser amounts of active medicine than their labels advertised.
That J&J and its McNeil Consumer Products subsidiary have recalled millions of other over-the-counter products, including children's Tylenol cold medicines, after they were found to contain slivers of metal particles and excessive amounts of active ingredients, has also garnered Issa's attention.  
"Regrettably, one of the patterns emerging at the FDA is one of failure," said Issa at a hearing with the pharma last fall. "Johnson & Johnson does not get a pass. This will mar the company's image for years to come."  
At that time, then-FDA Deputy Commissioner Joshua Sharfstein told Issa and his colleagues on the House Oversight Committee that the FDA would more closely monitor a Puerto Rican drug plant monitored by McNeil "until the company earns our confidence back." But according to Issa, on a recent visit to the facility in San Juan, he learned that FDA inspectors had yet to inspect the plant.  
In his letter to Hamburg, Issa stated that Maridalia Torres, the FDA's Puerto Rico district director, confirmed that neither she nor her staff had visited the San Juan plant since September 2010.
"Moreover, Ms. Torres and her staff have not even reviewed the corrective actions undertaken by McNeil and have instead relied on a third-party compliance officer employed by McNeil to provide them with information," Issa added.
According to Issa, Torres cited a lack of FDA resources as the reason for the FDA's inaction—which Issa called "deeply troubling" news because McNeil previously agreed to reimburse the FDA for all costs of its "inspections, investigations, supervision, analyses, examinations and reviews" deemed necessary to evaluate McNeil's compliance.  
"I find this excuse deeply troubling and inconsistent with the resources made available to the FDA in the legal consent decree," Issa wrote to Torres. The Congressman has also requested all records related to disciplinary actions FDA has taken against its employees related to the Motrin recall.  
The FDA has not issued a comment on the letter.   On June 15, J&J announced that it will close manufacturing plants in San German, Puerto Rico, as well as in Ireland—along with an estimated 1,000 jobs—as part of what it calls a "restructuring plan."

S.C. court orders J&J unit to pay $327M in Risperdal case
SPARTANBURG, S.C.—A South Carolina judge last month ordered Ortho-McNeil-Janssen Pharmaceuticals, a unit of Johnson & Johnson, to pay more than $327 million in penalties for alleged deceptive marketing of the antipsychotic drug Risperdal.  
According to the Circuit Court for Spartanburg County, Janssen repeatedly violated the state's consumer-protection laws by sending a 2003 letter to doctors touting Risperdal as superior to rival drugs and including deceptive information in the product's warning.  
"There is absolutely no doubt in my mind that the desire to protect market share overshadowed the good judgment of those in control at Janssen," said Judge Roger Couch in his 17-page ruling.  
Saying it does not believe the dissemination of a U.S. Food and Drug Administration-approved package insert constitutes a violation of the South Carolina Trade Practices Act, Janssen said it will appeal the ruling. Janssen fully disclosed Risperdal's health risks and properly marketed the antipsychotic medicine, the company maintains.
According to J&J's regulatory filings, Risperdal's global sales peaked at $4.5 billion in 2007 and declined after the company lost patent protection. The drug generated $3.4 billion in sales in 2008, or 5.4 percent of J&J's total revenue. Sales of the drug fell to $527 million last year, according to a January earnings report. A long-acting version of Risperdal, Risperdal Consta, generated $1.5 billion in sales last year.  
Following the news, J&J's shares fell 39 cents to $66.09 in New York Stock Exchange composite trading.
Code: E071123



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