Drug Industry Daily - May 28, 2010 Issue

Vol. 9 No. 104

McNeil May See Criminal Penalties Over Recall

The FDA is considering criminal penalties against the Johnson & Johnson (J&J) subsidiary responsible for a massive recall of OTC children’s drugs.

Testifying at a House Committee on Oversight and Government Reform hearing Thursday on McNeil Consumer Healthcare’s quality problems, CDER Office of Compliance Director Deborah Autor said the situation has been referred to the FDA’s criminal investigation unit.

The agency is also considering enforcement actions that may include seizure and injunction as a result of the ongoing pattern of GMP issues, she said.

McNeil issued a voluntary recall April 30 of more than 40 OTC pediatric medicines, including children’s Tylenol. It was the company’s third major recall in the past eight months due to quality problems, according to the committee briefing documents (DID, May 27). The FDA is looking into hundreds of adverse events, including 37 deaths, linked to the recalled products.

McNeil and its outside consultant are developing a comprehensive action plan on quality improvements and will share the plan with the FDA by July 15, J&J Consumer Group CEO Colleen Goggins said.

But the committee questioned FDA officials on the agency’s ability to handle significant product quality issues, such as those seen with McNeil, and several lawmakers have pledged to fight for mandatory FDA drug recall authority in the wake of McNeil Consumer Healthcare’s recent recall of some of its OTC children’s medicines.

Committee Chairman Rep. Edolphus Towns (D-N.Y.) said he would introduce legislation to give the FDA that authority. The agency also should have the power to order a halt in drug production, Towns said. Ranking member Darrell Issa (R-Calif.) agreed to work on bipartisan legislation granting the agency additional authorities.

The only civil monetary penalties the FDA can impose for drugs relate to specific application requirements, Deborah Autor, director of CDER’s Office of Compliance, testified. It would help if the agency could financially penalize companies for good manufacturing practice violations, she added.

Another issue raised in the hearing was an allegation that, rather than conduct a recall, McNeil hired contractors in 2008 to visit gas stations to purchase Motrin products that were potentially subpotent. According to a document obtained by DID, contractors were instructed to act like customers and make no mention of a recall.

The FDA’s San Juan office was aware of McNeil’s use of the contractors, who were performing an inventory check, Goggins testified.

Towns called the practice a “phantom recall,” adding that after the FDA confronted McNeil, the company recalled the affected products.

The FDA is using these events as part of an ongoing review of its recall process, and the agency is developing clear expectations and standards for recalls, FDA Principal Deputy Commissioner Joshua Sharfstein told the committee.

Moving forward, the agency will develop new procedures to use what it learns at one plant to guide its inspections of other facilities run by the same company, Sharfstein said. And if the FDA does not get a satisfactory response from a subsidiary, it “will not hesitate to go over their heads to their corporate parents,” he noted, adding that the agency went to J&J management in the McNeil case.

Meanwhile, the agency will continue to investigate manufacturing issues related to McNeil’s Fort Washington, Pa., plant, including evaluating compliance at other McNeil facilities. — April Hollis


Feingold Bill Calls for Drug Reimportation, Medicare Price Negotiation

Drugmakers may face a renewed battle in Congress over prescription drug reimportation and authorization for the government to negotiate prescription drug prices under Medicare Part D.

Sen. Russ Feingold (D-Wis.) introduced the Fair Pricing for Prescription Drug Act (S. 3415) this week, building on previous legislative efforts by Sens. Byron Dorgan (D-N.D.) and Bill Nelson (D-Fla.).

The legislation would allow the U.S. to import FDA-approved drugs from Australia, Canada, Europe, Japan and New Zealand, saving the federal government $19.4 billion over 10 years, Feingold says. It also would save consumers at least $50 billion, he adds.

The bill would authorize HHS Secretary Kathleen Sebelius to negotiate prescription drug prices on behalf of Medicare Part D beneficiaries. Such negotiations have been prohibited since the program was created in 2003.

Allowing price negotiation would put Part D in line with the Department of Veterans Affairs, which negotiates prescription drug prices, generating significant savings, Feingold says.

But others question whether the measures would generate the savings their proponents claim. For example, if U.S. pharmacies were permitted to import drugs from foreign countries, they would inevitably raise the prices of those products before reselling them to American consumers, Edmund Haislmaier, a senior research fellow at the Heritage Foundation, told DID.

“I think that [the bill] is something that will become a perennial,” Haislmaier said. “It will always be offered and will always go nowhere.”

PhRMA did not respond by press time to a request for comment on the bill, but the group has consistently opposed reimportation proposals. After Dorgan and Montana Gov. Brian Schweitzer asked HHS to sign off on a pilot project that would allow their states to import lower-priced drugs from Canada last month, PhRMA said the drugs are risky and the pilot wouldn’t produce taxpayer savings (DID, April 26).

Dorgan, with the backing of Sen. John McCain (R-Ariz.), had pushed for a reimportation measure to be included in the healthcare overhaul, but the provision did not make it into the final bill (DID, June 26, 2009).

The Fair Pricing for Prescription Drug Act can be found at www.fdanews.com/ext/files/FairPricingAct2010.pdf. — David Belian


NICE Recommends First Biosimilar for the UK Market

The UK’s National Institute for Health and Clinical Excellence (NICE) has recommended approval of its first biosimilar — Sandoz’s Omnitrope for treatment of child growth deficiencies.

The injectable Omnitrope (somatropin) also was the first biosimilar available in the EU when it was approved for use there in 2006. The biosimilar is comparable to Pfizer’s Genotropin, which is licensed in the UK along with five other versions of somatropin, NICE says.

In addition to Genotropin, Omnitrope will join Eli Lilly’s Humatrope, Novo Nordisk’s Norditropin SimpleXx, Ipsen’s NutropinAq, Merck Serono’s Saizen and Ferring’s Zomacton in the UK market. But the biosimilar could have an edge. When more than one product is available, the least costly option should be used, NICE says.

Sandoz hopes NICE’s recommendation signals a wider acceptance of biosimilars in the UK and the EU. “This is an important decision, the ramifications of which go far beyond the UK,” Ameet Mallik, global head of biopharmaceuticals at Sandoz, said.

Sandoz markets one other biosimilar in Europe, the erythropoietin Hexal/Binocrit (epoetin alfa). It was approved by the EU in 2007 to treat patients suffering from anemia as a result of kidney failure or chemotherapy. Hexal/Binocrit is equivalent to Amgen’s Epogen and Centocor Ortho Biotech’s Procrit. — Jonathan Block


Wyeth Sues Purchaser in Dispute Over Robitussin Recall

Wyeth has filed a lawsuit against an indirect purchaser of its drugs, saying the company purposely withheld more than $1 million in payments following a dispute over a recall of the OTC cough treatment Robitussin.

Quality King Distributors (QKD) withheld the $1.3 million payment because it felt it was owed the money for returning the Robitussin (dextromethorphan) products after a Wyeth recall in 2007, Wyeth says in a complaint filed this week in the U.S. District Court for the Eastern District of New York.

QKD was not owed the money, the suit says, because Wyeth provided refunds only to direct purchasers of the drug. QKD purchased its drugs from intermediaries.

QKD was aware of this stipulation but attempted to get payment from Wyeth by misrepresenting itself as a direct purchaser, Wyeth alleges. The suit cites an email from QKD Vice President Louis Assentato stating knowledge of the plan.

QKD disputes Wyeth’s allegations. “QKD contacted [Wyeth] directly, told them they were an indirect account and got permission to return the goods,” Anthony Viola, an attorney with Edwards Angell Palmer & Dodge who is representing QKD, told DID.

In Wyeth LLC v. QK Healthcare, Inc. and Quality King Distributors, Inc., Wyeth is seeking at least $1.3 million in damages and additional punitive damages. — David Belian


EMA: Statistical Signal Detection Helps Identify Adverse Events Earlier

Statistical signal detection can lead to earlier warning of many drug-related problems, but it should be used as an addition, rather than an alternative, to standard pharmacovigilance practices, according to a European Medicines Agency (EMA) study.

The retrospective study compares the use of statistical signal detection with standard pharmacovigilance procedures, using data submitted to the EU’s EudraVigilance database between September 2003 and March 2007.

Standard procedures include active surveillance, clinical trials or periodic safety update reporting to discover signals of a possible causal relationship between an adverse event and a drug. The EMA’s statistical signal detection method mines the database for these signals.

The study looked at 405 incidents involving adverse events. Of those, statistical signal detection led to earlier detection of 217, or 54 percent, of the events, the study notes. Seventy-nine events were picked up by signal detection after being identified by standard methods, and 109 were not signaled during the study period.

The EMA, which has incorporated statistical signal detection into its vigilance program, recommends using a combination of routine pharmacovigilance and statistical signal detection for optimal safety monitoring of drugs. — Meg Bryant


Sanofi’s Prostate Cancer Drug Meets Survival Endpoint

Sanofi-Aventis’ investigational prostate cancer drug reduced the risk of death by 28 percent in a multisite Phase III trial.

The median overall survival for patients treated with cabazitaxel, combined with prednisone/prednisolone, was 15.1 months, according to updated trial results. That compares with 12.7 months for patients treated with a combination of mitoxantrone and prednisone/prednisolone. Overall survival was the primary endpoint.

The trial, conducted at 146 sites in 26 countries, included 755 patients whose metastatic prostate cancer progressed following treatment with docetaxel-based chemotherapy.

Blood-related adverse events were neutropenia, leucopenia, anemia and febrile neutropenia. During the trial, 4.9 percent of subjects died, mainly due to neutropenia, a chemotherapy-related blood disorder. Non-blood-related events included diarrhea, fatigue and asthenia.

Cabazitaxel received priority review from the FDA, Sanofi-Aventis says, adding that it also has filed for EU approval. — LaCrisha Butler

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