Congress has questions for J&J, FDA

Lawmaker says FDA lacks sufficient oversight of the pharma’s Puerto Rican plants

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WASHINGTON, D.C.—Following a series of recent productrecalls by Johnson & Johnson (J&J), a United States Congressman hasvoiced concerns that the U.S. Food and Drug Administration (FDA) lackssufficient oversight of the pharma giant's operations in Puerto Rico.
According to Rep. Darrell Issa, R-Calif., the FDA's failureto monitor J&J's manufacturing problems in Puerto Rico is "deeplytroubling," and as chairman of the House Committee on Oversight and GovernmentReform, he detailed his concerns in a recent letter to FDA CommissionerMargaret 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 storesin 2009 without announcing a formal recall. Under current law, the FDA does nothave the authority to force a company to recall a product, regardless of thethreat to public health. No serious injuries or deaths have been tied to therecalled painkiller, but J&J said the affected pills contained lesseramounts of active medicine than their labels advertised.
That J&J and its McNeil Consumer Products subsidiaryhave recalled millions of other over-the-counter products, including children'sTylenol cold medicines after they were found to contain slivers of metalparticles and excessive amounts of active ingredients, has also garnered Issa'sattention.
Regrettably, one of the patterns emerging at the FDAis 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 imagefor years to come."
At that time, then-FDA Deputy Commissioner Joshua Sharfsteintold Issa and his colleagues on the House Oversight Committee that the FDAwould more closely monitor a Puerto Rican drug plant monitored by McNeil "untilthe company earns our confidence back." But according to Issa, on a recentvisit to the facility in San Juan, he learned that FDA inspectors had yet toinspect the plant.
In his letter to Hamburg, Issa stated that Maridalia Torres,the FDA's Puerto Rico district director, confirmed that neither she nor herstaff had visited the San Juan plant since September 2010.
"Moreover, Ms. Torres and her staff have not even reviewedthe corrective actions undertaken by McNeil and have instead relied on athird-party compliance officer employed by McNeil to provide them with information,"Issa added.
According to Issa, Torres cited a lack of FDA resources asthe reason for the FDA's inaction—which Issa called "deeply troubling" newsbecause McNeil previously agreed to reimburse the FDA for all costs of its  "inspections, investigations,supervision, analyses, examinations and reviews" deemed necessary to evaluateMcNeil's compliance.
"I find this excuse deeply troubling and inconsistentwith the resources made available to the FDA in the legal consent decree," Issawrote to Torres. The Congressman has also requested all records related todisciplinary actions FDA has taken against its employees related to the Motrinrecall.
The FDA has not issued a comment on the letter.
On June 15, J&J announced that it will closemanufacturing plants in San German, Puerto Rico, as well as in Ireland—alongwith 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 Risperdalcase
SPARTANBURG, S.C.—A South Carolina judge last month orderedOrtho-McNeil-Janssen Pharmaceuticals, a unit of Johnson & Johnson, to paymore than $327 million in penalties for alleged deceptive marketing of theantipsychotic drug Risperdal.
According to the Circuit Court for Spartanburg County,Janssen repeatedly violated the state's consumer-protection laws by sending a2003 letter to doctors touting Risperdal as superior to rival drugs andincluding deceptive information in the product's warning.
"There is absolutely no doubt in my mind that thedesire to protect market share overshadowed the good judgment of those incontrol at Janssen," said Judge Roger Couch in his 17-page ruling.
Saying it does not believe the dissemination of a U.S. Foodand Drug Administration-approved package insert constitutes a violation of theSouth Carolina Trade Practices Act, Janssen said it will appeal the ruling.Janssen fully disclosed Risperdal's health risks and properly marketed theantipsychotic medicine, the company maintains.
According to J&J's regulatory filings, Risperdal'sglobal sales peaked at $4.5 billion in 2007 and declined after the company lostpatent protection. The drug generated $3.4 billion in sales in 2008, or 5.4percent of J&J's total revenue. Sales of the drug fell to $527 million lastyear, according to a January earnings report. A long-acting version ofRisperdal, Risperdal Consta, generated $1.5 billion in sales last year.
Following the news, J&J's shares fell 39 cents to $66.09in New York Stock Exchange composite trading.

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