Shire Pharmaceuticals Taking Matters Into Their Own Hands

 

Shire Pharmaceuticals  will pay $56.5 million to settle allegations that it violated the False Claims Act by engaging in unlawful drug marketing and promotion practices of several drugs.  Shire manufacturers and sells pharmaceuticals including Adderall XR, Vyvanse and Daytrana, which are approved for the treatment of attention deficit hyperactivity disorder (ADHD) and Pentasa and Lialda, which are approved for the treatment of mild to moderate active ulcerative colitis. 

The settlement resolves allegations that Shire violated the False Claims Act by making false and unsupported claims related to Adderall XR, Vyvanse and Daytrana and that Shire promoted Pentasa and Lialda for off-label uses not approved by the FDA and not covered by federal healthcare programs. As part of the settlement, Shire entered into a Corporate Integrity Agreement that requires comprehensive compliance safeguards, oversight of Shire promotional activities, and compliance certifications from Shire’s board of directors and  management.

Glaxo Smith Kline In Trouble In China! More Medical Fraud!





GlaxoSmithKline has been fined a record 3 billion yuan ($488.5 million) for bribing doctors. A verdict was handed down by a Chinese court, which also sentenced several of the drugmaker’s executives to up to four years in prison. A court in Changsha, China, found the Chinese branch of the British pharmaceutical company guilty of paying bribes to doctors to boost sales of its products and ordered it to pay the biggest fine ever imposed by a Chinese court.
 
Separately, the London-based multinational pharmaceutical and biotechnology company is facing a number of allegations of unethical behavior by its doctors. Investigations are ongoing in Syria, Jordan, Lebanon and Iraq. GSK also disclosed in late May that it is under investigation by the U.K.’s Serious Fraud Office. GSK executives confessed in July 2013 to commercial bribery and tax-related crimes, including paying physicians and hospitals in order to bolster drug sales. Chinese officials said the scheme involved some 3 billion Chinese yuan in payments since 2007. From 2004 to 2010, physicians were allegedly bribed to use GSK drugs for conditions that, in some cases, they weren’t even designed to treat.

Millenial Media Stock Fraud!

 



An investor of Millennial Media, Inc. (MM) has filed a federal securities fraud class action complaint in the U.S. District Court for the Southern District of New York. The complaint alleges that the company and certain of its officers and directors violated the Securities Exchange Act of 1934 between March 28, 2012 and May 7, 2014. Millennial Media is a digital advertising company that provides mobile advertising solutions to advertisers and developers in the United States and internationally.

 

Millennial Media Is Accused of Misrepresenting its Performance

According to the complaint, shares of Millennial Media fell multiple times, representing a total decline of 86.56% from the stock's class period high. Shares of Millennial Media initially declined $5.38 per share or over 37% to close at $8.95 per share on February 20, 2013, following a February 19, 2013 press release announcing lower than expected revenues for the fourth quarter 2012 and bleak revenue guidance for 2013. Following subsequent declines, shares of Millennial Media fell most recently on May 7, 2014, after the company announced: (i) revenue for the first quarter of 2014 was again below analysts' projections; (ii) dour revenue guidance; and (iii) the resignation of the company's Chief Financial Officer, Michael B. Avon. As a result, Millennial Media's stock declined $1.99 per share, or over 37% percent, to close at $3.36 per share on May 8, 2014.

The complaint further alleges that Millennial Media failed to disclose that: (i) its technological products were not fully functional when announced, leading to rushed products with poor performance; (ii) it had little ability to track and report end-user clicks, leading to over-billing and customer abandonment; and (iii) corporate acquisitions the company undertook did not offer the business synergies claimed but were utilized to fill holes in Millennial Media's capabilities and further presented integration challenges for the company.

Health Canada VS FDA Did They Really Think They'd Win?



Whatever the FDA told Health Canada has had an effect. Days after Health Canada said it would talk to the FDA about Apotex, the regulator has banned the import of finished dosage forms and APIs from two of the drugmaker's plants in India.

Health Canada initially responded to the FDA putting Apotex's finished dose plant in Bangalore, India under import alert by asking the company to quarantine products manufactured at the facility. The quarantine bought Health Canada time to learn why the FDA issued the import alert and formulate its own response. Six days after calling for the quarantine, Health Canada has banned the import of 30 finished products--and a similar number of APIs--that Apotex manufactures at its Bangalore plants.

The regulator has also banned almost 20 APIs--and 50 products in which they are used--from IPCA Laboratories. A common thread links the regulatory actions: Data integrity. "This latest information puts into question Health Canada's trust in the reliability of data that all three plants are required by law to provide to demonstrate the safety and quality of their products," Canadian health minister Rona Ambrose said in a statement.

Reports of data integrity failings at IPCA emerged after FDA visited a plant in July and issued a Form 483. Staff at the IPCA site allegedly falsified temperature records, tweaked integration parameters and overwrote raw data. FDA inspectors visited Apotex around the same time, leading to a warning letter detailing the discarding of undesirable assay results and other data integrity problems.

Hospira Guilty of Having Foreign Particles in Injectable Medications According to The FDA

FDA cites Hospira for drug manufacturing violations Drugmaker Hospira said Wednesday that it received a warning letter from the (FDA) Food and Drug Administration regarding poor manufacturing quality at one of its facilities in Australia. The FDA inspected Hospira's drug manufacturing building in Mulgrave, a suburb of Melbourne. Hospira manufactures specialty injectable drugs including mitoxantrone at the facility. The FDA wrote that there were “significant violations of current good manufacturing practice regulations for finished pharmaceuticals,” according to a company disclosure. For example, the agency said that it found impurities in the injectable drugs and that it appeared Hospira was unaware of the situation. Lake Forest, Ill.-based Hospira said the warning letter would not halt production or shipment of drugs from the facility, and it “is evaluating what corrective actions may be required.” “The company takes this matter seriously, and intends to respond fully and in a timely manner to the FDA's warning letter,” Hospira said in its filing. Hospira officials were not available for further comment. Hospira does not anticipate the issue will dampen its 2014 financials, but if the FDA demands large-scale changes, it could “be significant to our ongoing business and operations,” Hospira said. Warning letters from the FDA are not entirely uncommon among pharmaceutical companies. To date in 2014, the FDA has issued a dozen warning letters to drugmakers based on manufacturing or product quality concerns. Hospira's specialty injectable drugs were a big driver in the company's improved earnings in the second quarter of this year.

Valeant Shortcomings Caught By FDA

 

Pharma Manufacturing  reports that the FDA has

posted a warning letter stating that management at

Valeant Pharmaceuticals failed to properly oversee a

contract manufacturer that supplied it with Sculptra

Aesthetic (injectable poly-L-lactic acid). In particular, the

FDA found no evidence that anyone at Valeant had

reviewed and approved the vendor’s deviation report

after the manufacturer stopped production to fix

problems affecting drug quality. The article says that the

FDA “wants to see evidence Valeant has taken steps to

improve its monitoring of CAPAs and review of supplier

deviation reports.” However, Valeant is confident it can

resolve the issues raised and has already divested

Sculptra Aesthetic as part of a deal with Nestle’s

Galderma unit.

Sculptra Aesthetic, a facial injectable that is marketed to smooth wrinkles. The product competes with Juviderm, which is sold by Allergan. Valeant is trying to buy Allergan, which also sells Botox, for $53 billion in conjunction with Pershing Square Capital Management.

 

Nonetheless, the letter raises the possibility that Allergan and its supporters may use the agency warning to support their argument that Valeant cutbacks focus too heavily on areas other than marketing, which may jeopardize R&D or patient safety. Earlier this week, the Allergan board reiterated that the Valeant offer is “grossly inadequate and substantially undervalues” Allergan.

We asked Valeant for comment and will update you accordingly. [UPDATE: Shortly after we posted, Valeant released a statement that says, in part, the warning letter "pertains to the management of Valeant's contract manufacturers, rather than Valeant's own internal manufacturing."  A Valeant spokeswoman adds that Sculptra Aesthetic was sold shortly after the inspection.]

 

 

Over Charging Overdraft Fees -- Thanks Comerica Bank

 

New York- Final approval has been granted in the $14.5 million settlement of consumer fraud class action involving overdraft fees charged by Comerica Bank NA. The class action involved people who had been charged overdraft fees on their Comerica Bank accounts between 2004 and 2010. The Comerica overdraft class action lawsuit alleged the bank posted debit card transactions in dollar amounts ordered from highest to lowest so as to maximize the number of overdraft fees it could levy against its customers.
According to the lawsuit, rather than declining transactions that would put a customer into overdraft, Comerica authorized the transactions, subsequently processing them in an order that would increase the banks’ overdraft revenue.

Eligible class members include anyone who held a Comerica bank account in Arizona, California, Florida, Michigan or Texas and incurred one or more overdraft fees as a result of Comerica’s non-consecutive posting of transactions between 2004 and 2010. Specific class periods vary by state.

The Class Periods by state are:

• For Settlement Class Members who opened accounts in Arizona, the period from February 18, 2004 through August 15, 2010.

• For Settlement Class Members who opened accounts in California, the period from February 18, 2006 through August 15, 2010.

• For Settlement Class Members who opened accounts in Florida, the period from February 18, 2005 through August 15, 2010.

• For Settlement Class Members who opened accounts in Michigan, the period from February 18, 2004 through August 15, 2010.

• For Settlement Class Members who opened accounts in Texas, the period from February 18, 2006 through August 15, 2010.

Eligible class members must have had two or more Overdraft Fees caused by debits posted to their accounts on a single day during the time period listed above. For further information on the Comerica class action lawsuit settlement, and to download forms, visit: http://comericabankoverdraftsettlement.com