fair balance

Week in Review, September 4, 2012

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The PharmaCertify™ Team

At last, this past weekend was the time to dust off the pompoms and break out the stadium seats! Fall “officially” arrived with the start of the college football season! This is truly the most wonderful time of the year! Decorating the car with magnets and flags, preparing a game day feast for family and friends, and let us not forget the ever important ritual of face and body painting. Good times, good times. After such festivities and a long holiday weekend, it’s hard to focus and get back to work, but we’re here to help kick off this first work week of fall with the News Week in Review.

We’ll kickoff this week’s review with a story of kickbacks. Omincare has struck an agreement in principle in a whistleblower suit that accuses the company, and its owner, of paying kickbacks when it purchased a pharmacy services company. The government declined to join the suit. Omincare has agreed to settle the suit, but the company’s owner has not, and that case continues.

Pharmaceutical sales reps in India haven’t exactly been cheerleaders for their industry, as made obvious by the day-long strike by the Federation of Medical and Sales Representatives’ Associations of India. The group protested against threats to job security, high prices of drugs and corporate corruption in the industry. In a letter, the FMRAI said the effort to shift responsibility for corporate corruption onto sales representatives has led to reps being banned from hospitals and medical institutions. The group says the true corruption is occurring at the corporate level and it is demanding that a statutory code of ethics be enacted.

And now for the halftime show! Taking the field is the American College of Informatimusicology with their salute to obtaining your medical information. Sit back, relax and enjoy the show!

The California Assembly passed a bill that will amend the state’s False Claims Act. The amendment will more closely align California’s law with the federal statute. Changes in the California law include increased protections for whistleblowers, provisions for awards to relators even if those relators were involved in the action that led to a violation, increased penalties for violations, and broadening of the definition of what constitutes a claim. The bill has been sent to the governor for signature.

The much anticipated FCPA guidance from the government appears to be advancing down the field ahead of schedule. Assistant Attorney General Lanny Breuer had said the guidance would be released in November, but now sources say the government will release the guidance in advance of the OECD meeting in October. The release could come this month with the officials from the Justice Department scheduled to speak about the guidance at the National Conference on the FCPA.

Some Georgia men may find themselves wearing a black and white striped uniform, but it won’t be as referees. The Securities and Exchange Commission charged eight men with insider trading related to Sanofi-Aventis buying publically traded Chattem, a pharmaceutical products company. The SEC says one of the men, an accountant, learned of the pending sale from a client who had come to him to discuss the tax implications the Chattem purchase would have on his stock options. The accountant then shared the information with four friends and as the cliché goes, “they told two friends, and they told two friends, and so on, and so on.”  The SEC said the group made just over $500,000 in trades. Four of the accused have agreed to settlements with the government without admitting wrongdoing. Cases against the other four men are moving forward.

Well folks, the clock has run down on this game, and all that’s left is to tune up the band and sing the Alma Mater before we head out of the stadium. We hope your team, high school or college, emerged victorious over the holiday weekend! Have a great, short, work week everyone.

Week in Review, August 27, 2012

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The PharmaCertify™ Team

Time is a ticking on summer with Labor Day just around the corner and now is the time to squeeze in those final cookouts and road trips. Of course, any proper barbecue or cross country trip wouldn’t be complete without a list of great summer tunes. Remember that great anthem that you heard all summer long and brought back great memories when you heard it years later? Well, as you start building this year’s Labor Day weekend playlist of guilty pleasures, we have a bit of “list” to tune up ourselves, the News Week in Review.

There’s been a British invasion over at Shire as the company joins the Association of the British Pharmaceutical Industry (ABPI) as a full member. Regarding the decision, company representatives said, “we seek to play a role in the development and growth of our industry, so joining the ABPI will be one way of contributing to this.”  Shire will also have a representative joining the ABPI Board of Management.

Two congressmen are not singing the praises of the current 510(k) approval process for medical devices. In a letter to the head of the FDA’s Center for Devices and Radiological Health, the pair expressed concern that faulty medical devices are able to reach the market through a loophole in the 510(k) approval process. The congressmen would like to see the FDA’s authority extended to deny approval for devices with designs that are based on devices that have previously been recalled.

On the legal front, former baseball star, Eddie Murray, and Abbott executive, James Mazzo, were indicted by the SEC on charges of insider trading related to the purchase of Advance Medical Optics by Abbott. Mr. Mazzo, former CEO of Advance Medical Optics, is alleged to have shared non-public information regarding the sale with one of Murray’s teammates. Murray learned of the sale from the teammate and profited from the inside information. Mr. Mazzo denies the allegations while Mr. Murray has agreed to a settlement with the SEC, but has denied any wrongdoing.

A former employee at Abbott is whistling an interesting tune about the company’s marketing practices for its cholesterol drug, TriCor. A new whistleblower case has been filed alleging the company used misleading and off-label marketing practices and provided kickbacks to doctors, which all led to Medicare and Medicaid paying for unnecessary prescriptions.

The definition of a foreign official under the FCPA, an oldie but goodie, was making the rounds on the anti-bribery playlist last week. This time, the case involves a Haitian telecommunications company. One of challenges to the defendants’ conviction centers on whether Haiti Teleco could be considered an instrumentality of the government simply because Haiti’s national bank owned a majority of shares in the company. In its brief, the government said 97% of the telecom company is owned by the bank, thereby making it an instrumentality of the government. The government also said the defendants could have requested an opinion from the DOJ as to whether the telecom company counted as an instrumentality.

Boehringer Ingelheim wants to “blind you with science,” but not in the typical fashion. Rather than announcing a breakthrough drug, the company announced they launch a social game that lets players run their own lab. The game, Syrum, is scheduled for beta trial in September. The company says they developed the game to educate “players about the pharmaceutical industry in a fun and engaging way.”  Game on!

And so we’ve reached the end of our playlist. If you’re like us, you’ll soon be breaking out the seersucker suit and white shoes for one final spin as you relish the memories of another summer season? Have a great week everyone. Enjoy the Labor Day festivities!

Week in Review, August 13, 2012

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The PharmaCertify™ Team

The thrill of victory, (US Women’s soccer team), the agony of defeat (Aly Raisman and Catalina Ponor both finding themselves out of a bronze medal due to gymnastics’ tie break rules) as well as the human drama of athletic competition (Oscar Pistorius and the first Saudi female athletes), has played out in London as the Olympics came to a close this weekend. And shockingly it ended without an overload of Miley Cyrus’ “Party in the USA” from the broadcast team at NBC. Something to be thankful for! Now it is time to return to the grind. If you’ve been glued to your computer for the around the clock, live stream, we’ve got your back with the News Week in Review.

In the Olympic spirit, an international group of researchers conducted a study regarding the disclosure of conflicts of interest in medical journals. The researchers targeted articles published by physicians and scientists that were reportedly involved in off-label marketing activities. The group found that one in seven authors fully disclosed their conflict of interest. Of the articles reviewed by researchers, only 15% contained adequate disclosure. Researchers are concerned because journal authors may have a strong influence on the prescribing habits of other physicians considering an off-label therapy.

Not defeated but most likely in some agony, KV Pharmaceutical filed for bankruptcy. The company’s CEO said the company has not realized the full value of its most important drug because the FDA has not enforced KV’s marketing exclusivity on the product. Since the exclusivity has not been enforced, several state Medicaid programs have made access to the drug more difficult.

Forest Labs has received another yellow card, in the form of an untitled warning letter, from the Office of Prescription Drug Promotion at the FDA, for statements made by two of its sales representatives. According to the letter, the representatives failed to communicate the drug’s appropriate patient population as well as its limitations of use. In addition, the reps allegedly minimized the risks associated with the product. The OPDP is especially concerned because the company is already under a CIA.

A law firm in Hong Kong has issued a report indicating that more Asian countries are joining in the anti-corruption game. While the FCPA and UK Bribery Act remain the top dogs in driving anti-corruption reform, individual countries are increasingly enacting their own anti-corruption laws. The group found that while the laws are similar in structure, enforcement varies from country to country.

And speaking of anti-corruption, there was certainly a whirlwind of enforcement activity last week. First on the podium is Fresenius Healthcare AG, the world’s largest provider of dialysis equipment and services. The company notified the SEC and DOJ it was conducting an internal investigation into possible violations of the FCPA. Next up, generic drug maker Teva says it has received a subpoena for documents related to its business practices in Latin America. Teva is cooperating with the feds and has hired independent counsel to conduct an investigation. Rounding out the anti-bribery “awards,” Pfizer  announced FCPA settlements with the government for over $60 million. The company’s subsidiary, Pfizer H.C.P. Corporation, agreed to pay $15 million to resolve an FCPA investigation and will enter into a Deferred Prosecution Agreement with the DOJ.  Pfizer H.C.P. admitted to paying $2 million in bribes to government officials in Russia, Bulgaria, Croatia and Kazakhstan. The DOJ says self-disclosure and cooperation led to a reduction in the base fine and the company is not required to hire a corporate monitor. Apart from the subsidiary settlement, Pfizer Inc. and Wyeth negotiated settlements totaling $45 million with the SEC, to resolve civil FCPA charges.

Well, that brings us to the end of this week’s Review.  We’ll be going through a bit of Olympics withdrawal this week without the nail-biting competition, or of course, those awesome interactive Olympic-themed Google Doodles! On the up side though, we can finally look forward to a good night’s sleep. That television coverage to midnight and beyond is a killer! Time to get back to normal, and that includes keeping an eye on the news for all of you. Have a great week everyone!

Week in Review, August 3, 2012

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The PharmaCertify™ Team

A tropical storm is churning in the Atlantic, the summer Olympics are going strong and the temperature is steaming hot. Yes, summer is in full swing, but over the weekend the first glimmer of fall appeared! The NFL kicked off its pre-season with a game between the Cards and the Saints. Relief from the heat is on the horizon! You could practically feel the crisp air and see the falling leaves. While there was only one game this past weekend, the rest of the league will be in action soon, so you still have time to dig that foam finger or team towel out of storage. Before you do though, take a gander at the week that was. Down, set, hike! Here we go.

Let’s kick off this week with news of pharma and med device advertising going digital. A publisher of medical journals and texts says advertisers are moving to digital platforms. Why… because that is where the doctors are. Use of iPads by medical professionals is on the rise. Medical journal publisher, Wolters Kluwer, has commitments from 50 companies, including several top pharmaceutical and medical device companies, to advertise in a digital format. To encourage companies to adapt their ads, the company no longer offers the option to purchase print only ad space and instead they bundle print and digital ad space. As it turns out, more time is spent viewing journal ads through apps than through traditional print. Several manufacturers are also incorporating video in their ads.

Pay-for-delay deals are facing a possible judicial sack on both sides of the Atlantic. Here in the US, the Third Circuit Court for Appeals issued a decision that such arrangements are anti-competitive. The Federal Trade Commission has been critical of pay-for-delay deals, and a spokesman for the FTC said the decision by the court was a step in the right direction in “solving this very real problem.” Both generic and branded drug makers argue that the deals are simply a way for solving patent disputes. Across the pond, the European Commission has brought the first anti-trust case against a drug maker for a pay-for-delay deal. A Danish drug company is accused of violating EU anti-trust laws through deals with generic companies that delay the entry of a generic competitor for as much as two years. The Commission says the drug maker may have caused consumer harm through its deals. The company refutes the charges and says its practices are compliant with both EU and national competition laws.

Olympus, the world’s largest maker of endoscopes, is calling a penalty on itself…well a potential penalty. The company discovered “irregularities” in a doctor training program in Brazil and has reported the matter to the DOJ. The company says a violation of the FCPA may have occurred. According to Olympus, the issue springs from the way the company may have handled expenses for travel, food and entertainment for doctors. The DOJ is also looking into the company’s marketing in the US.

Over at Bayer in the UK, there’s been an acknowledgement of a breach of the ABPI Code. Apparently, an employee created and distributed drug information without the company’s knowledge. Three documents were that had not been through the company’s review process were distributed. Some of the volatile material in the documents included comparative claims, inaccurate data, lack of fair balance, and the discussion of license uses. In all, the company has admitted to 12 breaches of the Code.

Vermont has not moved the ball forward in quelling pharmaceutical spending in the state. Despite the transparency brought by the state’s disclosure law and the banning of gifts, pharmaceutical companies have continued to spend at pre-law levels. With changes in the statute, the collected data can be difficult to compare, but according to the state’s Attorney General’s office, the level of spending has been roughly the same the law was passed.

Like the summer, the clock is ticking down on this week’s Review. We hope everyone locates their tailgating essentials in preparation for the weekend’s games. It may still be a bit warm to enjoy our tailgating favorite, chili, but a few burgers and dogs on the grill and an ice cold beverage should hit the spot. Have a great week everyone!