The PharmaCertify™ Team

Stormy weather! Have you had some? While lightning, high winds and hail are certainly no fun, there are parts of the country that really needed the rain that came with them. If you’re facing another rainy, stormy day, we are thinking of you and have just the ticket to pass the time…this week’s News in Review.

The storm clouds parted for the industry in Texas. The state’s Supreme Court ruled pharmaceutical manufacturers are not responsible for communicating a drug’s risks, even when the drug is marketed directly to patients. The decision overturned a previous appellate court ruling. The case at hand involved a patient who developed a Lupus-like syndrome after taking Remicade. The patient and her husband blame the drug, and say an informational video they watched at a physician’s office did not adequately communicate the risks associated with use of the drug. The Supreme Court ruled that the drug company provided adequate warning information to the patient’s physician, and since the patient had visited with her physician and decided to take the drug prior to viewing the video, there was no need for them to make an exception to the learned intermediary doctrine.

The tempest surrounding the Vermont data mining law may finally have subsided. Following the Supreme Court’s decision that effectively overturned the law, a U.S. District Court for Vermont has decided the state must pay IMS Data $2.4 million in legal fees. The company had asked for just over $4 million in fees, and the state asked that the amount be reduced to just under $1.5 million. The court settled on $2.4 million, bringing the total Vermont has had to pay to $4.1 million ($1.7 million went to PhRMA).

The time for has come for Travelers Insurance to put up that umbrella of theirs. Cephalon has brought suit against the insurer to stop them from attempting to recover $17.4 million the company claims it paid to cover off-label prescriptions for a cancer pain medication. Cephalon says federal law provides the FDA with the authority to deal with off-label promotion and does not give Travelers the right to file a suit.

Rounding out the litigation round-up, a new suit has been filed against Abbott related to off-label use of an anti-seizure medication. Plaintiffs claim the manufacturer failed to provide adequate warning on the product’s label regarding the risk of birth defects if women use the drug while pregnant.

China’s data privacy laws are leaving companies stranded in the rain during an FCPA investigation. A survey of FCPA compliance professionals reveals that the laws are impeding investigations into possible violations of the FCPA. Chinese data privacy law is very strict when the document in question could be categorized as a state secret. Experts say that since China so broadly defines a “state secret,” examining documents outside the country’s borders is difficult.

The pharma industry in India has decided to not fight the winds of change, and, in principle, has agreed to enforcement of the Department of Pharmacy’s marketing code. A representative of one of the country’s industry groups said a few companies have blemished the reputation of the entire industry. The Department of Pharmacy has agreed to make the code more practical and implementable. The code could be in place by the end of the year.

Well you’ve reached the end of this week’s Review! Is the rain still falling in your neck of the woods? Look on the bright side, all that rain gave you a good excuse for not doing any yard work during the weekend. Stay dry and have a great week everyone!

The PharmaCertify™ Team

Whew! The past few weeks certainly have been hot. Kinda makes you want a jump in a pool or run through a sprinkler doesn’t it? Or better yet, hit the beach! The cool ocean water, the sea breeze evaporating the sweat from your forehead, a cooler of ice cold…um…water (hey, this is a family blog) by your side. Devine, isn’t it? If you’re lucky enough to pack up the minivan and head to the coast this weekend, we salute you! Grab those beach chairs, beach towels and your sunscreen and get your cool on! For those of us not so lucky, we’ll have to sit in our air conditioned living rooms and pretend. But before any of us can escape to the real or metaphorical beach, we have Friday to tame. As you gather you’re reading material for the weekend, take a read of the week that was…the News Week in Review.

The change in the Massachusetts gift ban is not all sunshine and sand castles with med students in the state. In June, over 100 med students, residents, and physicians sent a petition to Massachusetts governor, Deval Patrick, asking him to keep the gift ban in place. Accompanying the petition was a letter from Harvard and Brown medical students expressing concern that the trust between doctor and patient is eroding because of the perception the profession was  “on the take” from the life sciences industry. On July 3, the governor responded, saying the change in the law was a small one and would afford companies a better opportunity to educate medical professionals about new medications and devices. He also said loosening the state’s regulations would better align with the PhRMA Code. The med students say the PhRMA Code should be a starting point, not the standard.

Might the wave of the first corporate charges under the UK Bribery Act be beginning to swell? Perhaps, and the lucky winner is…BP. The Serious Fraud Office has brought BP into a bribery investigation concerning one of the company’s contractors in Azerbaijan. No BP employees are suspected of having paid bribes, but under the Bribery Act, the company could be held liable for the actions of its contractor. So don’t forget those vendors and third parties when you’re planning your anti-bribery training.

Orthofix will be heading to the shore with $7.4 million less to spend on the boardwalk. The company and the DOJ reached a settlement to resolve bribery charges involving a former distributor in Mexico. After an internal investigation, the company notified the DOJ that a distributor may have paid bribes to Mexican health officials. Orthofix has entered into a Deferred Prosecution Agreement with the DOJ and Consent to Final Judgment with the SEC. The $7.4 million payout represents $5.2 million in profit disgorgement and $2.2 million in fines.

Continuing to surf that anti-corruption wave, we have a blog from Tom Fox about the GSK settlement. Wait, wait you say…that wasn’t an FCPA or Bribery Act settlement. No it wasn’t but, Mr. Fox highlights a couple of provisions in the GSK CIA that should be of interest to “FCPA compliance practitioners.” The first provision was GSK’s agreement to change the way it compensates its sales force by removing sales goals from certain territories. The other item of note was the agreement that any executives who engage in illegal activities would be required to return their bonuses and long term incentives.

For our friends in Texas, we realize the beach could be quite a haul. So for future reference, you might want to consider taking a dip in the water park this dentist is building at his home. Oh, and according to the state’s AG, he may be building it with your money, since the dentist in question is at the center of two large Medicaid fraud suits.

Well, I hope we’ve helped you decide which piece of summer reading you’ll be taking along on that visit to your own personal “beach.” Keep cool this weekend everyone…don’t forget the sunscreen!

The PharmaCertify™ Team

What a week – record heat and dangerous storms that led to widespread power outages. Seems Mother Nature brewed up some “fireworks” of her own this week. We hope everyone has kept cool during this record heat wave, especially those who found themselves without power. The weekend is almost here. So book some quality pool time, or relax inside in the a/c and get a rousing game of canasta going to escape what promises to be a hot weekend. But before you start working on your game night menu, take a gander at what was cooking in the news this past week. Time for the News Week in Review.

Obviously, the hot story of the week was GSK’s $3 billion settlement with the government. In case you missed it, the company pled guilty to two counts of misbranding and one count of failing to report safety data, and will pay $1 billion in fines and forfeiture on the criminal offenses. On the civil side, the company agreed to pay $2 billion to settle False Claims Act pricing fraud allegations. Most of the offenses occurred between 1998 and 2003, with some price reporting issues dating back to 1994. As a result of the settlement, GSK will also enter into a CIA with the OIG.

A number of states immediately publicized their share of the historic settlement. Here’s a smattering of who got what in the GSK lottery: Ohio, Indiana, Massachusetts, Rhode Island and New Jersey.

Apparently, one of the more salacious tidbits revealed in the complaint against GSK was that the company paid Dr. Drew Pinsky $275,000 to speak about Wellbutrin in a manner in which it would not appear he was speaking for GSK. According to the complaint, Dr. Drew’s payment was for two months work in 1999. Yes, you read that right, 1999. Based on the media response you’d think this happened last month. We’ll just chalk it up to a slow news week.

Moving on, an SEC official is advocating a compliance defense for the FCPA. Jon Jordan, a senior investigations counsel in the commission’s FCPA unit, published an article noting the existence of a compliance defense through the UK Bribery Act, and said the U.S. should consider similar defense for the FCPA. Such a defense would require that companies demonstrate they have sufficient procedures in place, Jordon says.

Over to India, where one has to ask, is the Department of Pharmaceuticals going to bring the heat down on the industry? The Department has scheduled a meeting with the industry to discuss making the drug marketing code mandatory. The voluntary code seeks to put an end to the provision of gifts and incentives to physicians. The meeting is in response to a letter from a member of Parliament stating she had received evidence the code was not being followed. Members of the Medical Council of India, the group that regulates doctors, are also scheduled to attend.

It may be winter in Australia, but seems folks are pretty hot over the recently updated Medicines Australia Code of Conduct. The Code was submitted this week to the Australian Competition and Consumer Commission for approval, but even before the details were known, critics said it did not go far enough in bringing transparency to the financial relationship between physicians and the industry. The details are out, and companies will have to disclose aggregate payments to all physicians for speaking, consulting, serving on advisory boards, and educational sponsorships. The Code, which goes into effect in January, also bans the provision of branded items, such as mugs and pins, and personal gifts to physicians.

Feeling the financial heat, KV is suing the FDA for the agency’s failure to stop pharmacies from compounding a version of the company’s pre-term labor drug. KV claims the FDA is putting the financial interest of insurers over patients by allowing the compounding practice to continue. The active ingredient used by pharmacists to compound the cheaper drug is widely available, but has not been cleared by the FDA. KV says if the FDA fails to act, the company will be bankrupt in three to six months.

That brings us to the end of this week’s News Week in Review. We hope you all enjoyed your mid-week holiday. Next year, as you celebrate the heroic actions of George Washington, Thomas Jefferson, Benjamin Franklin et al, a South Carolina lawyer claims we should honor whistleblowers as well. Really? Talk about a stretch to promote your business.

Keep cool everyone, and have a great weekend!

The PharmaCertify™ Team

The smell of peanuts and Cracker Jack, and the ping of the bat are hanging in the air of Omaha, Nebraska. The College World Series was in full swing this week, and will reach its conclusion, perhaps, over the weekend. Today’s game, featuring the Arkansas Razorbacks and South Carolina Gamecocks (repeat anyone?), will determine who faces Arizona in the finals. As much as we love America’s pastime around here, the games can get a little long. So to keep it interesting, we offer a little reading material – this week’s News Week in Review.

Both of the teams in tonight’s game are members of the SEC. Another SEC (the Securities and Exchange Commission) was making news this week when it gained approval to notify former Siemens executives they were on the hot seat with the US government. The SEC is pursuing civil charges against the executives for violations of the FCPA. The Commission received permission from a federal court to notify the defendants via notices in German newspapers and e-mails to their lawyers. The former executives will have 20 days to respond.

Medicines Australia is voting on a new Code of Conduct. On deck for consideration is the reporting of physician spend information. The measure, which would include the reporting of payments for speaking and hospitality, is supported by many of the industry’s largest companies. Some in the industry fear the measure will discourage doctors from agreeing to speak. As for physicians, the Australian Medical Association says it will not stand in the way of the new Code.

Seroquel (Quetiapine) has been put on waivers by the Department of Defense. Now doctors in CENTCOM will have to sign a waiver to prescribe the drug for troops. The drug is being prescribed, off-label, to deal with insomnia and Post Traumatic Stress Disorder (as are other atypical anti-psychotics). As the use of anti-psychotics rose, evidence began to mount that the drugs could cause irregular heartbeat and even death. Seroquel’s label does warn of cardiac issues. Concern over the cardiac affects and widespread use of the drugs prompted the DOD to take measures to more closely monitor their use, and in the case of Seroquel, restrict the use altogether.

The UK Bribery Act may have been thought of as a home run in the fight against corruption when it was passed over a year ago, but with little legal action occurring since the law went into effect, some have been left feeling a little underwhelmed. Here’s the good news though, the law did prompt action among multinational corporations to get their anti-corruption compliance ducks in a row. That’s good news because according to the OECD’s Working Group on Bribery, the Serious Fraud Office is working on 11 cases and has 18 other cases under consideration. Have you fired up your anti-corruption training yet? If not, we can help.

Directly from the world of baseball (sort of) comes news that a baseball hall of famer, along with a senior Abbott executive, is being investigated by the SEC for insider trading. The investigation stems from the purchase of Advance Medical Optics by Abbott. The SEC believes the former player, along with a teammate and others, profited from advanced knowledge of the sale. The Abbott executive is believed to be partly responsible for leaking the information prior to the purchase.

Worried that the FDA may take you out at the plate if you do the social media slide? Well, your man on the ground, Pharmaguy, reports that the FDA is too busy with all the low hanging fruit in violative product promotion to worry about social media. While attending a conference on social media, Pharmaguy started a discussion regarding meta tags and how the organic search results were essentially branded ads without the required safety information. A supposed expert in the audience said the FDA was too busy dealing with all the low hanging fruit to be worried about such things. Pharmaguy’s belief that the FDA is interested it the issue now is based on a Notice of Violation letter issued to Novartis about its use of meta data and a Facebook share widget.

Well that’s about it everyone. We’re headed out to get the bratwurst started on the grill, and prepare for tonight’s game. Before we go, one more obscure story you may not have heard about. The U.S. Supreme Court decided that drug sales reps do not have to be paid overtime. And someone out there says the decision should not prompt crying among sales reps.  (There’s no crying in pharmaceutical sales, people.)

Have a great weekend everybody, and Fear the Fish!

Week in Review, June 15, 2012

Bigger than the secrets of the LOST island, bigger than Sam and Diane, and bigger than the ambiguous fate of Tony Soprano was the question “who shot J.R?”.  If you missed out on that little piece of television history, no need to look for your friendly, local TARDIS to go back and experience it. Dallas is back and re-booted for the 21^st Century! We just ask that this version be free of “it was all just a dream” storylines. But enough of this fiction, let’s get down to some fact-based drama and intrigue with this week’s News Week in Review.

Congressmen Henry Waxman and Elijah Cummings are disappointed that Wal-Mart hasn’t cowboyed up and provided them with information related to the company’s FCPA compliance program.  Prompted by the New York Times story alleging the company was paying bribes to government officials in Mexico, the pair has begun their own investigation into the matter. The congressmen have sent a letter to the CEO, blasting him for his refusal to allow company representatives to speak to them regarding the allegations of bribery in Mexico. They also have criticized the CEO for sending representatives from the company’s law firm to brief their staffs on the company’s FCPA compliance program. The lawyers were unable to answer any questions about the bribery allegations.

Despite hundreds of calls coming in on the SFO hotline, the investigation well remains dry. Last November, the Serious Fraud Office launched the confidential hotline to collect reports of potential violations of the UK Bribery Act. Calls have been coming in since the launch, with 350 logged during the first quarter of the year. However, the SFO has yet to launch an investigation. The agency has been dealing with constant budget cuts, limiting its investigative resources.

Rounding out this week’s anti-corruption roundup is a tale of the importance of third-party due diligence. Tom Fox shares the story of a UK man profiled in the Washington Post who led a life filled with fraud. After the man took his operation to Washington DC, he continued to con businesses and people, despite the information that existed about his activities in the UK. Fox sees the story as a cautionary tale of the need for third party due diligence in regard to the FCPA and UK Bribery Act. Both laws expect companies to understand that its third party relationships stretch beyond the sales end of the business.

In light of the pre-emption that will eventually be brought by the Sunshine Act, the Vermont Attorney General’s Office has amended its guide for 2012 disclosures under the state’s prescribed products gift ban and disclosure law.

The False Claims Act recoveries from the industry may be Texas-sized, but one DOJ official says the prevention of fraud should be the focus. Speaking to a group of lawyers, Acting Assistant Attorney General, Stewart Delery, said that government had recovered just over $11 billion under the False Claims Act. The majority of the recoveries represented healthcare fraud cases. Delery said his office would continue to pursue non-monetary, proactive measures to prevent fraud, and he encouraged those in attendance (and their clients) to implement proactive compliance measures to prevent fraud from occurring in the first place.

The weather may always be pleasant and sunny for breakfast on the South Fork terrace, but for the industry, the Sunshine is obscured by clouds of uncertainty. A group of lawmakers have written to CMS to ask that the final rules for the Sunshine Act be delayed until “appropriate congressional committees of jurisdiction have had a chance to review the proposed rule and its impact on patients and the U.S. health system.”  (*cough*…comment period…*cough*) The letter listed several concerns, including the complexities in certain reporting requirements, the reporting of payments for clinical trial, and the burden on CMS brought on by over reporting due to the low reporting threshold. CMS has yet to respond to the letter.

Well folks, time to saddle up and ride off to the weekend. Have a good one everyone!

The PharmaCertify™ Team

Not so long ago, in a galaxy not so far away, in fact in the galaxy in which we live, there was a planetary event that would not be repeated in our life time…well unless cryogenics ends up working out. The transit of Venus occurred this week. We hope you had the opportunity watch the little black spot on the sun (the Police and Star Wars references in one paragraph…snap!) meander ever so slowly across the disk of the sun for nearly seven hours. As fascinating as it would be to continue this astronomy chat, we’ll bring it back down to earth with this week’s Week in Review.

Let’s start off the Review with a nice sunny story, shall we? A poll of primary and specialty physicians found that 56 percent of them are concerned about the upcoming spend reporting under the Sunshine Act. With the final rules still pending, physicians, hospitals and other stakeholders are concerned about the public presentation of the data. Their primary is that the public release of the data doesn’t paint the complete picture of the relationship between healthcare providers and the pharma/med device and bio industries.

Defying gravity? GSK has filed suit against Louisiana’s Attorney General, claiming the fee arrangement the AG has with private lawyers in the state’s suit against the company violates the state Constitution and the company’s constitutional rights. GSK claims the lawyers have a personal financial stake in the outcome of the trial. Under the agreement, the lawyers do not get paid unless the state wins an award against GSK. The state is seeking $10 billion in civil penalties along with damages, lawyers’ fees and expenses. In its court filing GSK said the company had a “legal right to face law enforcement decisions that are not structurally tainted by substantial financial incentives for the prosecutors to seek and extract substantial penalties.” We’ll end this with a quote from Steel Magnolias: “Louisiana lawyers do well, whether they want to or not.”

The Department of Justice has a settlement offer from Stryker in its orbit. The company has offered the DOJ $33 million to put an end to a federal investigation of one of its knee implants. The investigation concerns violations of federal law dealing with sale of device not cleared by the FDA.

There has been a “big bang theory” released from the Congressional Budget Office regarding the medical device tax. The CBO released analysis that said repealing the med device tax would reduce government revenues $30 billion over 10 years. A bill to repeal the tax was passed by the House Ways and Means Committee and sent to the full House for vote. During the committee hearings, Democrats asked Republicans to show how they would replace the lost revenue. In response, Republicans released a plan showing how they would generate nearly $44 billion in revenues over 10 years, alleviating pay-as-you-go concerns raised by the CBO report.

In other news regarding the med device tax, White House officials have threatened to veto the bill the repealing the tax. There are no plans to consider the bill in the Senate, so it probably would not pass if it gets there. As we all learned from School House Rock, a bill must pass both houses of Congress before the president can sign or veto it. Or, he can let it sit on his desk for 10 days before it comes law without a signature – just gotta love election year politics.

The number of adverse even reports received by the FDA rocketed up nearly 10 percent in 2011. Of the drugs receiving the top number of reports, only three were introduced in the last 10 years. Most of the top drugs carry prominent warnings about potential dangers. The increase in the number of reports is attributed to increased reports from manufacturers.

Is there a black hole of corruption developing in Britain? Transparency International warns corruption is more prevalent than is currently recognized in the country. The group says government and private concerns alike need to recognize the urgency of the problem and deal with it consistently and coherently. The group argues that any plans to dismantle the Serious Fraud Office should be put on hold. It further points out that not dealing with corruption could adversely affect the economic health of the nation, and European nations that are in dire economic straights are also those with weak anti-corruption safeguards.

The pharma Twitter universe is expanding. Some companies have one main feed on the social network, but a number are maintaining multiple Twitter handles. Companies appear to be taking advantage of what social media does best – speak to targeted groups. Companies are targeting their Twitter use for recruiting, communicating disease-specific information, and exploring philanthropy opportunities.

Well, fellow stargazers, that brings us to the end of this week’s News Week in Review. As we head to the weekend, don’t get rid of those eclipse glasses or pin hole viewers you used to observe the transit of Venus just yet.  It may be another 105 years before the next transit, but there is a full solar eclipse due in 2017. Make your plans now!! Have an out-of-this-world galactic weekend everyone!

Week in Review, June 1, 2012

Daaa-da-da-da-daa-daa. Ah, Pomp and Circumstance, (you got that musical reference from da-da’s right?) the perennial anthem of graduation ceremonies everywhere. It’s that time of year, when young ones (and not so young ones) don cap and gown, cross a stage to receive a blank piece of paper that commemorates years of hard work and dedication in pursuit of knowledge and education…always tear jerking for parents and family and liberating for the graduate. We celebrate these graduates’ achievements as they head off in to a brave new world. Whether that world is the work force or the first grade, we congratulate you all. In honor of graduates everywhere, we begin our own little “commencement” address – this week’s News Week in Review.

Brazil seems to be preparing to matriculate into the group of nations passing laws prohibiting the bribery of foreign officials. The Brazilian Congress is considering a law that would prohibit foreign bribery, however, the business community is pushing back against the law. A recent vote on the draft bill was delayed in order for the congress, business community and other stakeholders to work through some of their differences. There are three major areas of contention in the law: successor liability, the level of sanctions, and corporate strict liability.

In other foreign bribery news, we finally say goodbye to our old friend, the Lindsey Manufacturing FCPA case. The government has decided to drop its appeal of a judge’s decision to throw out the conviction of the company and two of its executives. After winning the first ever case against a company for violating the FCPA, the government saw that victory pulled away late last year when a judge tossed the convictions, citing government misconduct. Had the appeal moved forward, opening briefs from the government were due to be submitted June 1.

The state of Massachusetts is on its way to crossing the stage of allowing usage of drug coupons. Budget amendments in the state’s legislature would make the use of  co-pay and discount coupons legal. There are differences between House and Senate amendments that are to be worked out by a six member committee. Two issues to be resolved are the expiration of the coupons, and fines over raising the price of a drug.

The House Ways and Means Committee graduated a repeal of med device tax to the next grade. The republican controlled committee passed the Protect Medical Innovation Act, which would repeal the medical device tax that is due to go into effect next year. The committee has sent the Act to be voted on by the whole House next week. Some democrats on the committee are concerned the bill does not address how the loss in revenue from the repeal will be offset.

Senator Chuck Grassley is questioning the awarding of a “scholarship” by the National Institutes of Health to a doctor who had been previously banned from receiving funds from the NIH. The NIH awarded a $400,000 research grant to a psychiatrist who was previously banned from receiving funds from the institute. The ban came as a result of the physician’s failure to disclose $1.2 million in payments from a pharmaceutical company while he led a multi-million dollar federal study involving that company’s drug. A director at the NIH said the ban against the doctor had expired, and even if it hadn’t, the ban would not apply since he was working for a different university. The doctor in question is still under investigation by the OIG and DOJ, and Grassley questions whether the NIH had taken this into consideration in making its decision to award the grant. Grassley said the NIH risked sending the wrong message to physicians seeking federal grants.

As the industry prepares to take its first steps in the new world of disclosure, a study in the Archives of Internal Medicine finds that the disclosure of payments to physicians has little to no effect on prescribing habits. (insert shocked gasp here). The study focused on two types of drugs: statins and selective serotonin reuptake inhibitors (SSRIs). Using publically available data, researchers compared prescribing habits in states with disclosure laws to those that did not have such laws. The findings showed the laws had little to no effect on increasing the use of generics or reducing the cost of medication. One study author said that transparency was important in its own right, but if the aim of law makers is to reduce costly prescribing, more direct action may be needed.

Well, it’s about time to throw that mortar board and tassel in the air and head out to weekend of our future. (wow, that was hokey) If you’ll be spending part of your weekend packing for a trip to the Big Easy for the SPBT conference, you won’t be alone. We will too! Come on by booth 235 and say hello. And be sure to catch our presentation on creating a values-based compliance program on Wednesday!

In case you haven’t had your fill of graduation-themed fun just yet, here’s one last read. Have a great weekend everyone!

The PharmaCertify™ Team

Break out the white pants and seersucker suits! Its Memorial Day weekend, and summer has unofficially started! Woo hoo! It’s time to take the cover off the pool, fire up the barbeque and get our lazy, hazy summer days on! If you’re reading this, you’re probably in the same boat as us – watching the clock tick ever more slowly to the start of the weekend. Because we care about you, our dear readers, here’s a bit of something to read to pass the time. Without further adieu, this week’s News Week in Review!

So let’s dive right in with a fun little summer read. Good news for the coffee lovers out there. (Let’s face it we’ll all be downing this delicious nectar today as we wait on the clock to mercifully strike 5:00.) Turns out that all that coffee may help you live longer. A study funded by AARP and the National Cancer Institute (and Starbucks)  found that adults 50-71 who consumed two to three cups of coffee a day had a 10% lower risk of death. While the study’s lead author isn’t recommending people go out and start consuming coffee based on the results of the study, the study should make people feel better about consuming coffee (and buying stock in Starbucks).

Okay, onto more serious stuff. Developments related to the FDA user fees bill came crashing onto the beach like waves during high tide this week. The bill was introduced into the Senate early in the week and the amendments were flying fast and furious. First, Senator Orin Hatch of Utah introduced an amendment to repeal the upcoming medical device tax. Then just as quickly, Senator Dan Coates, a co-sponsor of the amendment, announced the amendment would be withdrawn, and that Senator Hatch intended to address the repeal of the tax in “another vehicle.”  Adding an amendment of his own was Senator Bernie Sanders of Vermont. That amendment would cause a pharmaceutical company to lose its product exclusivity if it were “found at fault for fraud involving a particular drug.” In a press release, Sanders cited case after case of incidences involving pharmaceutical companies and healthcare fraud, and said companies that defraud Medicare and Medicaid, or illegally market drugs, should not enjoy the government-provided monopoly for those drugs. Oddly enough, Senator Sanders was the odd-man out when the Senate passed the bill on Thursday with a 96-1 vote.

And you thought getting your brother-in-law to switch from charcoal to a gas grill was tough! A new study finds that physicians who limit contact with, or do not see, drug sales representatives are more likely to continue to prescribe drugs with a black box warning over newer therapies. The study found physicians with restricted access to drug sales representatives were four times less likely to move from a drug with a black box warning to a best in class drug than their peers without such restrictions. The study’s lead author says the increase of access restriction had an effect on physicians’ decision making beyond what is anticipated by healthcare systems and large group practices.

The OIG posted a video and transcript of the keynote address delivered by Inspector General Daniel R. Levinson to the Healthcare Compliance Association’s Compliance Institute. Mr. Levinson opened by commenting about the HCCA survey that revealed six out of ten compliances officers lose sleep over their job. He said he didn’t mind the bad guys stressing over doing the wrong thing, but he knew this audience was filled with the good guys. The Inspector General used a handy acronym to discuss the areas covered by the OIG – EPCOR (um…shouldn’t that be EPCOT?) enrollment, payment, compliance, oversight and remediation. He went on to explain the OIG’s role for each of these. He also covered the OIG’s enforcement authorities and social media presences.

Things are starting to heat up in the House of Representatives regarding Wal-Mart’s foreign bribery fiasco. Democrat House members have sent letters to the U.S. Chamber of Commerce and the Retail Industry Leaders Association (RILA) requesting information about Wal-Mart’s involvement in the lobbying effort for FCPA reform. The House members believe there are conflicts of interest in Wal-Mart being involved in a lobbying effort for reform of the FCPA while they were in the midst of an internal investigation for possible FCPA violations. The lobbying efforts were headed by the Chamber’s Institute for Legal Reform (ILR), and Wal-Mart has a representative on the Institute’s board of directors. Lawmakers have requested minutes of meetings from ILR’s board meetings.

The bribery pool is seeing an increase of folks swimming about. A survey by Ernst and Young finds that the number of top executives willing to pay a bribe to get or keep business increased 6 percent this year. Ernst and Young says top managers are underestimating the risk as they expand into new markets. The findings are particularly concerning due to the level of responsibility for the individuals involved.

Well folks, we’re a few ticks of the clock closer to the weekend. We’ll leave you with one last story to consider as you make your plans for the weekend. The FDA has pushed back the new labeling requirements for sunscreen six months. By my count, that puts us squarely in winter.

Have a safe and enjoyable weekend everyone!