pharmaceutical compliance

Week in Review, January 21, 2014

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The Serious Fraud Office adds Deferred Prosecution Agreements to its arsenal, doctors in the UK are looking for more transparency and one generic drug manufacturer gives up on China.

The teams for Super Bowl XLVII are set! The Seattle Seahawks and the Denver Broncos will do battle in New Jersey in February. Hmm, New Jersey…in February. Nothing against the Garden State (for many of us, it is home), but wouldn’t a warmer climate be more inviting for those with a ticket? Barring any blizzards, the game should be exciting as the top offense and top defense in the NFL face off. We know we’ll be tuned in, but until then there’s other news to address. Let’s kickoff this week’s News in Review.

February is shaping up to be a big month for the Serious Fraud office as well. Beginning next month, the SFO will be able to utilize Deferred Prosecution Agreements as a tool to deal with corporate bribery. The advantage to the SFO and to corporations is that agreements can be negotiated without prolonged court cases or the eventual debarment for corporations if they were found guilty through a trial. Implementing DPAs will bring its own set of challenges though. Judges in certain jurisdictions in the UK prefer justice to be doled out in court and not in advance. Consultation with judges prior to an agreement being signed should help, but the judges are not bound to accept the agreements. That leads to an issue of consistency in the process. If companies can’t rely on agreements being ratified by judges, they will be less likely to engage in the negotiations.

British doctors and academics teamed up to ask for more transparency in physician conflicts of interest. In an open letter appearing in the British Medical Journal, the group called on the General Medical Council to set up a general registry for physicians’ conflicts of interest. The letter cited an ABPI estimate that nearly 40 million pounds are paid to physicians by the pharmaceutical industry, and that the recipients of those payments are largely unknown. The letter said transparency into just who is receiving those payments “can only be good for medical practice.” A spokesperson from the GMC said that it could not require doctors to disclose payments without a change in law.

Generic drug maker Activis is scrapping its China playbook. The company announced it would cease operations in China. It’s CEO said China was not a “business friendly environment,” and there is too much risk in doing business there. The company has a small profile in China, and while it has not run into the issues some other pharmaceutical companies have of late, the CEO said he wasn’t confident that if anything did happen, the company would get a fair hearing.

2013 was another record setting year for False Claims Act recoveries, according to the DOJ. The DOJ collected $3.8 billion during the 2013 fiscal year. Of the $3.8 billion, $2.6 billion was from healthcare fraud recoveries. The majority of that $2.6 billion was from settlements with pharmaceutical industry companies.

Congress is calling for a review following CMS’ explanation for why payments for textbooks and journal reprints are not excluded from Sunshine reporting. The explanation provided by CMS did not sit well with members of Congress, and some are exploring options for changing the requirement. An aide to Maryland Representative Andrew Harris said the Congressman plans to add language to an appropriations bill to halt the collection of the data.

The fourth quarter’s here and it’s time to wrap this thing up. Before we dump the bucket of virtual sports drink over the head of this week’s Review though, we have to ask if you feel confident with your compliance training lineup for 2014. Do you need to add a new player or get back to training on the basics? The PharmaCertify™ suite of compliance training solutions includes two key players – Good Promotional Practices offers a comprehensive review of compliant product promotion practices and concepts for your sales team, and Commercial Compliance Overview is a comprehensive review of commercial compliance for your entire staff.

Have a great week everyone!

Week in Review, Holiday Edition

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With the holidays approaching, one co-pay charity falls onto the “not so nice” list, whistleblowers get the gift of protection against retaliation, and the state of Maryland finds an extra present of its own.

Well, here we are in the final stretches of the Christmas shopping season and either you’re resting peacefully, content in the knowledge that your mad dashes through mall mania are behind you, or you’re in full “take whatever is left on the shelf” panic mode. As you unwind with a cup of eggnog and a slice of recycled fruitcake, we offer a compliance-themed distraction of our own, with this edition of the News Week in Review.

Tis the season for giving, but at least one charity needs to be careful about the process. The Chronic Disease Fund (C.D.F), which provides co-pay assistance to patients with chronic conditions, has come under scrutiny for its relationship with pharmaceutical industry donors. Questions were raised in investor publications about the relationship between the charity and pharmaceutical manufacturers. C.D.F. has hired a law firm to review its practices and recommend new policies to comply with legal requirements. The organization’s president/founder has resigned.

In the spirit of the season, the U.S. Senate Judiciary Committee wants to give whistleblowers the gift of protection against retaliation. The Committee approved the Criminal Antitrust Anti-Retaliation Act of 2013 to protect whistleblowers involved in antitrust cases. The bill will allow for recourse against retaliation through a cause of action in civil court, through which compensatory damages would be possible. The bill has been sent to the House for approval.

Maryland is getting a little extra in its stocking this year since GSK has agreed to a $15 million settlement with the state over accusations the company improperly marketed three diabetes drugs. The suit was filed under Maryland’s False Health Claims Act. The company allegedly touted the drugs as being superior to competitive products, without justification, and allegedly neglected to share information about the heart disease risks associated with the drugs.

Speaking of GSK, the company announced it will no longer pay doctors to promote its drugs, and it will no longer pay for physicians to attend medical conferences. According to CEO Andrew Witty, the moves have nothing to do with the current investigation into the company’s business practices in China, but are rather an ongoing effort to “stay in step with how the world is changing.” The plans should be rolled out globally by 2016. The company also announced that starting in 2015 it will no longer compensate sales representatives based on the number of prescriptions written by doctors on a global basis. The revised compensation policy is already in place in the U.S.

The head of the Canadian Medical Association is among those caroling the approval of the move by GSK. The CMA president said it was a welcome change, and should serve as a “wake up call” for those who are too “cozy” with the industry. He said the CMA has had rules regarding relationships with industry companies for some time, and that he hopes the move by GSK will promote a larger transparency discussion in Canada.

With the final shopping hours ticking away, we won’t keep you from your appointed rounds (or from your happy dance if you happen to be in the “woo hoo I’m all done” category) any longer. We leave you with a reminder that if comprehensive compliance training on topics like on-label promotion, adverse events and the Sunshine Act are still on your own gift list, the modules and mobile apps available through the PharmaCertify™ suite of solutions offer  up-to-date and customizable content where your staff needs it most – in the field and at their fingertips.

Have a great holiday everyone!

New Week in Review, November 18, 2013

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The APBI amends its Code of Practice, a doctor in Scotland looks for Sunshine, PhRMA sues the state of Maine over drug importation, and a congressman from New Jersey seeks clarification on how food provided to CME program speakers and attendees is reported.

The big day is almost here…if you have a tween or teenager, you are probably well aware that the long-awaited opening of the film, The Hunger Games: Catching Fire, is this Friday! With a number of theaters premiering the film a day early, we’re left with precious few hours to practice our skills for the archery tournament and best braid contest. But before we prepare for our time in the Arena, we pause to present you with a week’s worth of compliance news, with the News in Review.

Our first “tribute” comes courtesy of the ABPI, whose members have agreed to amend the Code of Practice to include greater transparency on payments made to HCPs and healthcare organizations. APBI’s chief executive views the changes to the Code as an important first step in correcting the public’s misconception of the relationship between the industry and HCPs. According to a recent British Medical Journal article, he may be onto something. The article reported the results of a recent survey, which found 90% of the nearly 1,055 respondents felt that payments to HCPs should be made public.

As the ABPI moves on with determining the details of its transparency program, a Scottish doctor is hoping a Sunshine Act style law will “catch fire” in his country. The physician has petitioned the government to create a Sunshine Act of Scotland, which would publicly disclose payments to NHS healthcare professionals.

A compliance uprising has been started in Maine as PhRMA and several Maine pharmacy associations are suing the state over its drug importation law. The law allows Maine’s citizens to obtain prescription drugs pharmacies in Canada and from licensed retail pharmacies in the U.K., Australia and New Zealand. PhRMA, and the other plaintiffs, say the law violates the U.S. Constitution and federal laws that control the sale of drugs.

If you’re looking for more information on Open Payments and data submission, CMS has announced a series of webinars, designed to introduce features of the Open Payments system, on November 19. While the webinars are targeted to manufacturers and individuals responsible for creating data submission files for manufacturers, anyone is welcome to attend. A follow up question and answer session will be held December 3.

Speaking of “hunger games,” the language regarding meals at CME events continues to cause confusion. So much so that New Jersey Congressman Robert Andrews sent a letter to CMS requesting that the cost of food provided to speakers, faculty AND attendees of CME events be exempt from individual reporting requirements.

The rule already exempts the speakers and faculty as long as three requirements are met: the program is accredited by one of five designated organizations; payments or transfers of value are not made by the manufacturer directly to speakers or attendees; and the selection of faculty and speakers is not influenced by the manufacturer.

In his letter, Congressman Andrews points out that CMS has already acknowledged that accreditation bodies and industry standards create safeguards against sponsor involvement in educational content. He says the same logic should be applied to the meals provided to attendees.

Well, that’s the news for this week. We leave you this week with a recommendation for a different type of trilogy – one that weaves a compelling and engaging tale of compliance best practices and risk reduction across a broad array of topics. PharmaCertify’s Compliance Overview, Good Promotional Practices and On-label Promotion eLearning modules offer the regulatory and practical content your sales representatives and office staff need to understand the compliance rules and promotional policies that affect their daily activities. They’ve been met with rave reviews by learners of all ages!

Have a great week and, “may the odds be ever in your favor.”