medicine

Week in Review, September 4, 2012

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

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 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, April 20, 2012

NXLevel Compliance Team , ,

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!