government

Week in Review, August 27, 2012

NXLevel Compliance Team , , , , , , , , , , , , , , , ,

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 20, 2012

NXLevel Compliance Team , , , , , , , , , , , , , , , , ,

The PharmaCertify™ Team

It’s that time of year again. It’s the season when we’re inundated with television commercials compelling us to wait in long lines for the latest must-have items. It’s back to school time! And we have a reading assignment for you…this week’s News Week in Review. The bell is about to ring, pencils out please.

Medicines Australia is starting the school year with a group project: determine the best way to publically disclose information about payments to doctors. The organization’s Working Group on Transparency is comprised of members of the medical community, consumer groups and pharmaceutical companies. While Medicines Australia has stated its commitment to improving transparency of physician payments, the Australian Medical Association is concerned about the identification of individual doctors. Their concerns echo those that have been raised by medical groups here in the U.S. about the Sunshine Act, including the potential for misrepresentation of the data to the public.

The DOJ appears to be cutting back the amount of “school supplies” it requires of companies accused of FCPA violations. During 2012, the DOJ pulled back on the requirement that companies hire an independent monitor. Only three of seven companies have been required to hire the monitor thus far this year. The others have been asked to self-monitor and then report to the DOJ. In recent years, the problems with the independent monitors have been a source of embarrassment for the Department, and that may be the reason for the cut back. While we’re on the FCPA, check out this list of the top 10 corporate settlements. Guess what industry did not make the list?

A new study finds doctors are more likely to move sales reps carrying iPads to the head of the class.  According to the study, 65% percent of doctors say when they’ve seen reps carrying an iPad. More importantly, 35% of doctors say they are more likely to request a sample from a rep that is carrying an iPad, and 29% say they are more likely to prescribe.

We’ve reached the lunch portion of our “school day.”  If your beverage of choice is chocolate milk made with Hershey’s syrup, it may not be as nutritious as the label led you to believe. The FDA issued a warning letter to the chocolatier regarding wording on the labels of a couple of the syrups. One product said “plus calcium” and another used the wording “fortified with vitamins and minerals.” Neither product met the guidelines necessary to make those claims. The company has since changed the labels.

Vein treatment device maker, Vascular Solutions, seems to have gotten on the class monitor’s list. The company has announced the federal government will intervene in an off-label investigation. The investigation stems from a complaint filed with the U.s Attorney’s office alleging the company’s promotional practices cost the government around $20 million in damages. The company said it will continue to cooperate with the U.S. Attorney’s investigation, but will defend the case “as something that’s factually inaccurate and without merit.”

PhRMA, AdvaMed, Biotechnology Industry Organization (BIO) and Medical Imaging and Technology Alliance (MITA) teamed up on a letter writing assignment this week. The industry trade groups sent a letter to CMS this week regarding the pending final rules for the Sunshine Act.  The groups expressed their appreciation to CMS for their careful consideration of the many comments received on the proposed rules and requested CMS allow manufacturers 180 days to implement the final rule before beginning data collection.

Speaking of AdvaMed, a gold star goes to the group for its hiring program for returning military veterans. The program is called MedTech Veterans Program Boot Camp for Returning Heroes, and it will provide training in resume building and interviewing skills. Additionally, 25 vets will be provided mentors to help them transfer their skills into jobs in the med tech sector.

The bell is about to ring, so time to pack up and head to the next class. For those of you who are still on “summer vacation,” enjoy the final beach weekends before you’re rockin’ the school’s carpool line. Have a great week everyone!

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, July 27, 2012

NXLevel Compliance Team , , , , , ,

The PharmaCertify™ Team

The majestic tones of the trumpet and pomp of the kettle drum of the Olympic theme rang out on tellies across the world this past weekend with the launch of the 30th Olympiad in London. As exciting as all the sporting contests are, nothing was probably more anticipated than the opening ceremonies. Other than the few carefully leaked bits of information, the majority of the details were shrouded in the mists of Brigadoon. So when the veil of mist finally parted, what did you think? What was your favorite part? We’d give it to the parachuting “Queen”. So, with that in mind, Mr. Bean and the Chariots of Fire sequence wins the night (honorable mention to the bicycling doves.) With opening ceremonies over though, it is time to get down to the business of competing, and this week’s News Week in Review.

Our first story takes us to the 2016 Olympic host country of Brazil. The legislature there has again delayed a vote on the country’s proposed anti-bribery law. However, compliance professionals and others are not waiting on the vote to pass and are getting ready for the law now. According to the OECD, Brazil was the number four country receiving direct foreign investment in 2011. That trend is only expected to rise. Additionally the country will be hosting two key international sporting events in the very near future; the soccer (or football) World Cup in 2014 and the Olympics in 2016. These events will bring a flood of direct and indirect investment into the country. The country is expected to spend billions to make infrastructure improvements to prepare for both of these events. Construction and sports are typically fertile grounds for bribery to occur. As it stands now, the proposed law is built on two pillars: the tough sanctions for violators and incentives for companies to act ethically and comply with the proposed law. It is expected the law will be passed in 2013.

But, back to our current host city of London. Reports are that many high dollar tickets have remained unsold (hmmm…last minute trip anyone?). Could this be due to company restrictions on personal gift giving and receiving? A recent survey from the Society of Corporate Compliance and Ethics (SCCE) and the Healthcare Compliance Association (HCCA) suggests this could be contributing factor. The survey from the two groups showed that most companies are pretty restrictive of the gifts employees can give or receive. The survey found that more companies ban the giving of gifts by employees than receiving. Non-profits and healthcare were tops in banning the giving of gifts. Entertainment also is restricted, but more companies restrict the receiving entertainment than the provision of entertainment. Again healthcare led the way in restricting entertainment over other industries.

The FCPA professor passed the torch to some guest authors this week, three of the defense counselors involved in the first trial in the FCPA sting case. The three attorneys represented a UK citizen in the first group of defendants. They believe there were two overarching factors which led to the results of the first trial and the eventual failure of the prosecution: 1- the pre-trial exclusion of evidence of previous bad acts and 2- their unorthodox decision to call the government’s lead investigator as their only witness.  In the first factor the lawyers said the government intended to bring in seven examples of prior bad acts. They argued this would lead to confusion, and in the case of their client, if he had actually participated in these bad acts, it was not evidence that he intended to defraud the U.S. or violate the FCPA. The judge agreed, and the evidence was not permitted in trial.  In calling the government’s lead investigator as their only witness the lawyers admit they took a huge risk. However, it became clear to them that the government did not intend to have him or their key informant as witnesses. The team took the tactic to ask government witnesses about who made the key strategic decision regarding the investigation. When witnesses answered with the name of the lead investigator, it opened the door for the defense to call him as a witness to answer questions about the investigation. They were then able to illustrate the flaws in the government’s investigation. The resulting mistrial in the first case led the government to change its strategy for the second case.

If you do business with the government, the last thing you want to take a tumble on is a violation of the False Claims Act (FCA). With hefty penalties and treble damages not to mention the specter of exclusion all on the table for violations, companies have to take care to assure they do not run afoul of this piece of legislation. In 2009 and 2010 there were six significant amendments to the FCA brought around by passage of the Fraud Enforcement and Recovery Act and the Patient Protection and Affordable Care Act.  These six amendments are: the Anti-kickback liability; public disclosure and original source requirement; expansion of liability for overpayments; reverse false claims; elimination of the presentment requirement; expansion of the term “claim.”

Industry grants for CME took another dive in 2011. Industry support has been waning since 2008. According to the ACCME industry funding dropped by 11.4% in 2011. The money collected from ads and exhibits fees from industry did go up in 2011, but unlike the previous year, the revenue from these sources was not enough to keep CME in the black. The number of providers and overall attendance also declined in 2011.

The former President of R&D at Pfizer, John LaMattina, has an interesting suggestion in the wake of the loosening of restrictions in the Massachusetts gift ban. Bring the doctors to the researchers. Mr. LaMattina points out that while the charge to loosen the restrictions on meal provisions to doctors was led by Massachusetts Restaurant Association, pharma was not doing itself any favors by joining in. Public perception is that these meals are meant to entice doctors into prescribing expensive drugs, and by the industry arguing for the restrictions to be repealed, it was not doing anything to enhance its public image. LaMattina believes there is true value in physicians and industry representative communicating, but that perhaps there is a better venue in which the communication can occur. His suggestion is for companies to bring the doctors to the labs. In Massachusetts many large companies have research facilities. He points out doctors are very interested in the science behind the drugs, and in turn, the scientists at these facilities enjoy talking about their work. This makes the R&D facilities a great spot for companies and physicians to discuss products and exchange ideas.  What do you think? Gold medal idea, or false start?

That brings us to the end of this week’s News Week in Review. We hope you’ve enjoyed the weekend of competition. We sure have, and after Kazakhstan’s victory in the cycling road race, we’re sure Borat is pretty stoked as well. Have a great week everyone, and go Team!

Week in Review, April 20, 2012

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The PharmaCertify™ Team

Happy Earth Day everyone! So what are your plans for the day? We’ll be reducing, reusing and recycling here at the Week in Review. And, to celebrate Earth Day and Disney’s Animal Kingdom’s 14th anniversary (April 22nd), we may even take in a screening of the new film, Chimpanzee. Before you head off to get all green for the day, take a gander at the collection of electrons we call the PharmaCertify Week in Review.

We’ll start this week’s review with a story from a land known for its glorious green color, Ireland, where a program titled, “Solutions for Wellness,” is being launched by mental healthcare professionals. The program is sponsored by a drug company that manufactures psychiatric medication, and the company’s logo can be found in the print materials. Although no drugs are mentioned, the program has caused some to voice concerns about the line between promotion and education and conflicts of interest between the industry and the medical community. The Irish Pharmaceutical Association says companies are within their rights to support education campaigns as long as they do not mention a specific product, and that they work diligently to keep member companies apprised of their responsibility in this area.

The supporters of a new bill in the U.S. House of Representatives are hoping to have the FDA create some green in the life sciences industry. The bill, introduced by Mike Rogers of Michigan, would change the mission of the FDA. The new mission would include advancing public health by speeding innovation and spurring economic growth and job creation. The notion to change the mission statement was brought up several weeks ago during a hearing and again last week at a House committee meeting about industry user fees. The heads of both the medical device and drug divisions of the FDA are opposed to the changes, as is the consumer protection group, Public Citizen.

A government group in India wants to “clear the air” and let the Sunshine in. In a report to the Planning Commission, a steering committee on health suggested that India consider putting in to practice reporting requirements like those found in the U.S. Sunshine Act. The recommendation came along with a call to make the voluntary code of conduct created by the Department of Pharmacy mandatory.

A new study in Canada shows eleven percent of drugs are prescribed off-label, raising concerns about side effects and other consequences. Of the prescriptions written for off-label uses, 80% were for purposes for which there was no scientific evidence to support the usage. Central nervous system drugs were the ones most often prescribed for off-label uses.

There will be a little less cash in the coffers to cover the costs for the Earth Day party at a medical supply company in Tennessee. The company agreed to pay $18 million to settle allegations it violated the False Claims Act. After advertising free cookbooks to Medicare beneficiaries and verifying respondents to the advertisement were in fact Medicare recipients, the company allegedly sent the cookbook, along with medical supplies, to the individuals. They then billed Medicare and TennCare for the supplies. When the individuals returned the unwanted supplies, the company neglected to refund the money paid to the healthcare programs for reimbursement. In other settlement news, GSK has agreed to pay Idaho $2.8 million to settle charges the company overcharged the state’s Medicaid program.

Apparently, U.K. businesses need to look at recycling whatever training they have on the Bribery Act. A survey of 1,000 U.K.-based middle managers finds that just over 70% of them are not familiar with the Bribery Act. Of those who knew about the Act, over half said they had not received adequate training to be compliant. Representatives from Ernst and Young, who conducted the survey, say that businesses may have been lulled into a false sense of security due to the lack of reported cases.

Well, that brings us to the end of another Week in Review. Have a great and green Earth Day everyone!