The PharmaCertify™ Team

Congress is on vacation. The President is on vacation. The person in the office or cubicle next to you is on vacation. Yep, lots of vacation going on right now, but you know who isn’t on vacation? That’s right, the PC News Week in Review! Let’s get the ball rolling on this week’s review.

Will Pharma stay in the water when it comes to Facebook? ‘Tis the question of the week. Companies like J&J and AstraZeneca have pulled Facebook pages, where others like Pfizer and Sanofi are staying in. The industry is concerned about dealing with adverse event reports, off-label information and medical advice that appear in the comments. Some outside the industry say the concern is manageable and the industry is being overly cautious, and the FDA, well…

Turning a lovely shade of red, but not from a sunburn, is Bayer. The Prescription Medicines Code of Practice Authority (PMCPA), the watchdog arm of the Association of the British Pharmaceutical Industry, issued a reprimand against the company for improper promotion over tweets on two of the company’s drugs. No fines were levied against the company, but the reprimand will be published in medical journals.

The industry is taking a bit of a “staycation” when it comes to support of CME. According to the ACCME, industry support of CME fell for the third straight year as industry funding made up just 37% of income for CME providers. Companies are also spending less when it comes to advertising and exhibits at CME events. All of this comes as the number of doctors seeking CME is increasing.

The Office of Civil Rights (OCR) may be making a trip to court to collect $4.3 million in fines owed by Cignet Healthcare for violations of HIPAA related to refusing to provide 41 patients with their medical records. The case marks the first instance where the agency has not been able to negotiate a deal with a covered entity. OCR officials are stunned at Cignet’s refusal to even show up at court hearings in the matter. What is up with that? Were they afraid they would have to listen to a timeshare presentation or something? Don’t know why we should be surprised since they responded to fines by delivering 4,500 patient files to the lobby of the DOJ. Wow…just wow.

PhRMA tells the FDA it’s time to pack up the current drug name changing process. In response to an FDA request for comment, the group said the current process should be scrapped or overhauled to streamline the process. A drug safety organization says name confusion is the most common cause of medication errors, and the name testing program is an important safety measure.

The ACCME retreats on a proposal to not allow corporate logos appear on commercial support disclosures. The group asked for comment on the issue. The majority of respondents were not in favor of the move, saying that “text only” disclosures could be buried or simply overlooked, while logos increase transparency and offer a visual indication of who has paid the support.

Carl Ichan’s nominees for Forest Labs’ board of directors can hit the road, as it doesn’t appear they will be serving on the BOD any time soon. Early results in voting point to the nominees put forth by Forest as the winners of the election.

If your summer reading plans include medical journals, be wary of the pharmaceutical ads. A study that reviewed nearly 200 ads in medical journals found that less than 20% of them are completely compliant with FDA guidelines on advertising. The study authors point to a lack of resources at DDMAC as the reason for the problems in regulating the ads.

And speaking of reading, we wind up this week with a story that could have been ripped right out of your favorite vacation guilty pleasure read. A Mexico City lawyer representing Baxter International in a case against a trucking company was “caught on tape” offering to pay off an expert witness for the opposition. Baxter said the offer was not authorized, and the lawyer was no longer representing the company in the matter. For interesting read on whether the FCPA could be implicated in the matter, check out this blog from Tom Fox.

That brings us to the close of this week’s PC News Week in Review. August may be a big “vaca” month for many of us, but you know what never takes a vacation – compliance (oh yeah, we went there). As August winds down and the hustle and bustle picks back up in September, we can help you re-fresh old training or launch new compliance training on a variety of topics from the FCPA to the PDMA and everything in between.

If you are headed out on holiday yourself, be safe and have a great time! Send us a post card! We’ll be right back here when you return, ready to inform and even entertain you with all the news you missed.

Have a great weekend everyone!

Lauren Barnett, Compliance Content Specialist

August 15 brought to an end the days of pharmaceutical companies being able to turn off the comments on their Facebook pages, and oh the wailing and gnashing of teeth. Okay, maybe that’s an exaggeration, but several companies did take down pages in response. Why? A myriad of reasons that all boil down to fears over being able to remain in compliance with FDA regulations, without any guidance from the agency on the topic. To the FDA I say, get with it. Facebook (as well as other social sites) is how people research and communicate with companies, and with the case of healthcare, others who are in their same situation. Surely the agency has an opinion about how companies can use this medium to communicate with the public without the world caving in and being taken over by ad agencies and marketing departments. But lest you think this is yet another call for FDA guidance on use of social media (which, hello they need to get with it and deliver), let me pose this; the pharmaceutical industry needs to get with the program too. An article in Pharma Times said the following:

“Drugmakers say they are concerned that commentators may reference side effects or proffer medical advice, or mention brands without ‘fair balance,’ although critics of the stance argue their reluctance stems more from a lack of understanding about social media and fears about loss of control over brand image.”

I think the “critics” have a point; the industry may just not understand social media. Facebook is a great way to “advertise,” but that isn’t what it’s for, and to reduce it to just another to advertising vehicle is to do your brand a disservice. I see it as a great way to reach out to patients and share information, but whether the industry sees it the same way remains to be seen. As for brand image control, I’m not sure I buy that one as a reason for reluctance, because many companies manage to have a Facebook page that allows comments, and those companies have not yet had their brand image ruined. If one of the fiercest guardians of brand image, Disney, can have multiple Facebook pages, I think the pharmaceutical industry can handle it too.

Yes, the industry does have regulatory concerns to deal with, yes the FDA needs to join us here in the 21^st century and provide some guidance, but if the industry really wants to get involved with social media, it needs to loosen up a bit, and let social media be social.

The PharmaCertify™ Team

Just wondering, is anyone dizzy out there? Who needs a trip to the amusement park when you can ride the stock market rollercoaster? It has been one wild ride this week. Not as wild, but certainly just as fun, is this week’s PharmaCertify News Week in Review. For your safety secure any loose items, and keep your hands, arms, feet and legs inside that car at all times. With that said, we’re off!

It appears the ride with OIG has come to a complete stop for Forest Labs’ CEO Howard Solomon. The agency notified the company that they were no longer going to pursue efforts to exclude the CEO from participating in federal healthcare programs. In a statement, the government stated it had decided to stop the proceedings based on file documents and information provided by company attorneys.

J&J has reached an agreement to settle a misdemeanor criminal charge related to Risperdal marketing. However, the ride has not completely stopped for them as the company is still negotiating civil charges with the government. Forty states are also lined up to pursue charges against the company.

Merck may be getting on the Merry-go-Round with the government. The company received subpoenas related to the marketing of three of its drugs from 2004 to the present. In a SEC filing, Merck revealed that the subpoenas were received as part of a health care investigation under criminal statues. During the time frame in question, the drugs were primarily marketed by Schering Plough.

For your viewing pleasure, a video interview of former DOJ fraud and abuse director, Larry Freedman. Mr. Freedman discusses current and future trends in healthcare law enforcement, including individual prosecution and exclusion. He also questions if the government is overreaching in it tactics, and what companies should be doing today to protect themselves.

The Sunshine Act is no kiddie ride, and the pharmaceutical industry won’t be alone in feeling its impact. From possible public backlash from the exposition of a financial relationship with the industry to potential tax issues, the Sunshine Act will impact physicians as well, as issues like financial relationships with the industry and potential tax issues are revealed.

Are Pharma company Facebook pages down for good or will they simply undergo a refurbishment? Some companies have announced they will take down their Facebook pages. Among them are Janssen, with its ADHD Moms page, and sanofi with its VOICES page. Sanofi is directing users of the VOICES website to its company site, where comments can be sent in for  review before they are posted on a publically accessible wall.

The recently published ABPI guidelines on social and digital media aren’t quite the thrill ride communication and marketing professionals were hoping to see. The guidance has done little to clarify the acceptable digital communication practices for the industry. In turn, companies are simply not willing to move forward with, or commit to developing, digital communication plans.

The US Chamber of Commerce is proving it’s no Mickey Mouse operation, as the organization takes on the FCPA full force. The Chamber has a list of five issues they would like to see changed in the law. Critics of the lobbying effort complain that the call for changes come at time when the rest of the world is taking steps to deal with bribery and corruption.

That brings us to the end of the line. We hope you enjoyed the ride as much as we did.  Please gather your belongings, take small children by the hand, and watch your step as you exit the PharmaCertify News Week in Review and head in to a glorious weekend. Have a good one everybody!

The PharmaCertify™ Team

It was hard to tell which was louder this week: the screeching of Congress members’ tires as they peeled out of D.C. for summer break, or the wails of school children across the south as many saw their summer break end and headed back to school. Yep, it’s back to school time, so sharpen your No. 2 pencils, grab a seat and focus on the “board” – it’s time for the PC News Week in Review.

Finding himself at the head of the class this week was lawyer Michael Horowitz. The President has nominated Mr. Horowitz to be the Inspector General of the Department of Justice.  Mr. Horowitz has handled a number of FCPA cases, and is currently serving as the lead attorney for Pfizer in its FCPA case. Additionally, he has provided training to government attorneys in matters related to the FCPA. Seems like a good fit for the job considering the current push in FCPA enforcement.

Drug marketing, the kid everyone loves to pick on, got whacked again as concerns were raised over the “ads” users of the free Epocrates mobile app are forced to see. With nearly half of the nation’s doctors using Epocrates, critics are concerned that the drug industry-sponsored “Doc Alerts” will influence doctors to write prescriptions for expensive, less effective brand name drugs.  Doc Alerts can address a specific condition or medication, and can be targeted to physicians based on the types of drugs they look up in the app.  The founder of PharmedOut says patients are the ones who suffer the financial and health consequences of the influence of these ads.  Epocrates admits it can be difficult to balance the needs of both its pharmaceutical and physician customers, but says their first commitment is the value of the product to the physician.

Are laws needed to make sure authors of medical journal articles have “done their own work?”  Yes, say the authors of a policy paper in PLoS Medicine. The authors call the practice of ghostwriting of medical journal articles fraudulent, and say medical journals, institutions and other professional bodies have done little self-regulating to stop this practice. The authors are often not at all involved in the study, study design or analysis of data, and should not be allowed to sign their name to the study, the authors say. There is concern that such laws would allow for class action suits under the U.S. RICO Act.

Congress is considering relaxing the FDA advisory panel conflict of interest rules as part of an FDA funding bill. Current rules prohibit the FDA from having experts with industry ties on advisory panels. This has left many vacancies on these panels which provide recommendations on drug approvals, and has raised questions of whether the most qualified experts are being unfairly excluded. Citing a study which found that forty-four percent of cardiologist have no industry ties, critics say the FDA simply isn’t looking hard enough for its experts. They say the experts are out there, they just take a little more work to find. Some critics would like to see stronger rules. They believe even a past financial relationship will influence how a physician on a panel would vote.

Sounds like a fight might be brewing in the school yard as a pain drug monitoring company has its say about the qui tam suit filed by a competitor. Millennium Labs says it was part of a witch hunt by a competitor who alleged Millennium, along with several other competitors, violated the False Claims Act in their billing practices. The other suits were dismissed voluntarily. Millennium believes the suit against them was kept as a retaliatory strike over a defamation law suit Millennium filed against the relator in 2009.

This is not the only lawsuit trouble Millennium faces from competitors. Another lab company in Tennessee has filed a lawsuit alleging fraudulent billing practices and the provision of kickbacks to physicians.

Seeking assistance from higher education, Medtronic is giving Yale University a $2.5M grant to study its bone growth protein product, Infuse. The product has been at the center of a Congressional investigation into whether the side effects were downplayed in medical literature, as well as by company scientists who claimed certain side effects were due to surgical technique rather than the product.  The company will turn over all of its published and unpublished patient level clinical data as well as all adverse event reports. Yale will commission two CROs and will create a steering committee of advisors to review the data. Medtronic will have no input on the selection of either the CROs or the steering committee members, nor will Medtronic have any input over the release of data

Whether the kids in your area returned to school or not this week, the time is quickly approaching. (Hopefully the temperatures will be trickling down right along with the return to school! Man it was hot this week!) Is it time for some refresher training for your sales reps, marketing managers or other employees? Whether its refresher training, or freshen up training, PharmaCertify can help with our off-the-shelf, customizable compliance eLearning modules. We cover a wide range of topics including healthcare laws, good promotional practices and the FCPA.

Seems the bell for the weekend is about to ring, so we’ll wrap up this week’s review. Have a great weekend, a successful school year, and for those still on break, keep cool and enjoy these last few weeks.

The PharmaCertify™ Team

Finally, an agreement has been reached! After months of negotiating, name calling and media posturing, they did it! That’s right folks, there will be NFL football in the fall! As we enter the dog days of summer, we can rest assured that our Sunday afternoons in the fall will be filled with bratwurst and the beverage of your choice. Now that all is right with the world, we can move forward with this week’s PC News Week in Review.

Are there too many players on the field where False Claims Act (FCA) investigations are concerned? Lawmakers, Congress and lawyers seem to think so. Even the DOJ would like to see the cases resolved more quickly. However, with most cases being qui tam (1,341 as of January, according to a letter sent to Sen. Charles Grassley) and those cases taking around two years (or 13 months depending on who you believe) to investigate before the government decides to join in the suit, it seems as if speeding up the investigatory process is going to prove to be quite a challenge. Senators Grassley and Leahy of the Senate Judiciary Committee have introduced a bill aimed at speeding up the process. One law firm is urging companies under investigation to push the government to unseal cases more quickly.

False Claims Act cases aren’t the only ones loading up the line either. FCPA cases are also overloading the docket in federal court. The judge in the well known SHOT Show sting case is faced with a full docket as is, and the government says it will re-try the first group of defendants, whose trial ended in a mistrial. Lawyers are arguing whether this first group should be tried again before proceeding with the other defendants in the case. Lawyers for the government say there has been movement in plea arrangements for several defendants, and that should lower the case burden. The judge however is not convinced the government has the manpower to handle the load, and has told the lead lawyers in the case he will not accept excuses of manpower problems if one of the prosecutors is not able to participate in a trial.

Wisconsin’s largest hospital system has sacked the practice of providing free samples to patients. The ban is effective August 1. A senior vice president with the hospital system said the decision to stop the practice was largely based on safety concerns, but other institutions with similar bans say providing free samples encourages the use of expensive prescription drugs. Wisconsin’s Froedtert Health System enacted a similar ban in 2006 and then saw a 15% rise in generic drug use over the next two years. The ban will allow samples to be distributed in some cases, such as when patient has to learn how to use an inhaler or inject a drug.

Gearing up the offense is Kentucky AG, Jack Conway. This week, he filed suit against McKesson on several charges, including violation of the state’s Consumer Protection Act. The state is accusing McKesson of conspiring with First Data Bank to distort drug pricing information, thus costing the Medicaid program millions of dollars.

EU officials look to tackle the issue of industry-patient communication. Currently the EU bans drug makers from direct communication with patients, but those regulations are now up for review. The new regulations aren’t expected to allow the type of DTC advertising permitted in the US, but they will bring some sort of uniformity. Industry trade groups support the review, saying there is too much disparity in how countries across Europe handle the topic.

Experts at KPMG say the pharmaceutical industry needs to get its game face on when it comes to the UK Bribery Act and the use of CROs. According to the report, the use of CROs poses an increased risk that requires robust contract compliance efforts and increased awareness of what CROs are paying the healthcare providers.

After further review, a federal judge has dismissed two of three charges in an off-label promotion suit against Medtronic. The whistleblower suit alleges that Medtronic actively promoted biliary stents for off-label uses and caused false claims to be submitted. The whistleblowers in the case have charged they were terminated in retaliation for their refusal to go along with the off-label promotion. The judge dismissed one whistleblower’s retaliation charge, as well as the false claims charges, saying the relater failed to provide the detailed information required by the FCA.

We’re putting our name on it, and calling this week’s edition of the PharmaCertify™ News done. Go get ready for some football and head to the sports shop and stock up jersey’s and other assorted merchandise from your favorite NFL team. (Unless that team is the Dallas Cowboys, and then we’ll thank you to spare the assault on our eyes with that stuff). It’s almost football night in America! Have a great weekend everyone!

Lauren Barnett, Compliance Content Specialist

Recently, Main Justice published an article (here) summarizing the sentiments expressed during a panel discussion (also hosted by Main Justice) with healthcare industry lawyers regarding healthcare fraud enforcement. Some of my favorite quotes from the article are as follows:

From Chris Wray of King Spalding in discussing how the cases have changed over time said, “As you start seeing those cases become more and more subtle, you’re going to see more and more litigation. [Prosecutors] have gotten better at pursuing these cases. They’ve gotten more aggressive and they’ve gotten more savvy about how the companies operate, what works and where the pressure points are.”

Ralph Hall of the University of Minnesota in discussion the threat of debarment said, “If you’re a publically traded company and you are excluded from participation in healthcare programs, that is essentially the death penalty…because of what happens to your stock if you disclose that the government may be pursuing exclusion? What this means is many of these legal theories have not really been challenged in court.”

My favorite quote came from Laurence Freedman of Patton Boggs LLP, “Something is wrong here. The goal should not be maximum recovery. I’m not sure we should be bragging about how many millions of dollars we’ve gotten from pharmaceutical companies.”

I wholeheartedly agree with what they said! The vagueness of the laws and the changing tide of enforcement make compliance difficult. It seems to me the goal here should be to work with companies to achieve compliance, not racking up huge settlements under the threat of exclusion. Where there has been fraud, absolutely go after it. But, the government has a mighty large hammer in exclusion. Perhaps that hammer should be used more as tool in enforcement rather than as a weapon.

The PharmaCertify™ Team

“We’re having a heat wave. A tropical heat wave.” A huge section of the country is baking. Triple digits temps…high humidity...”might as well be walking on the sun.” However, you are happily sitting in your air conditioned space reading about the hot news of the week. Kudos to you! You have the right idea. Crank that A/C up and grab an iced beverage as you kickback and enjoy this week’s PharmaCertify Week in Review.

The hot topic this week has to be the announcement of an FDA proposal to regulate mobile apps related to health and medical needs. (It was really just a matter of time, wasn’t it?) The proposal would only target certain apps, and the agency will be seeking comment on the proposal. The types of apps the agency is concerned with are those that act as an accessory to an already regulated medical device, and those that turn a mobile device into a regulated medical device through the use of attachments, sensors or other devices.

A physician in Massachusetts may have been feeling a little hot under the collar as he wrote a response to a Rhode Island news website article about the financial relationship between doctors and the pharmaceutical industry. The website ran the usual and customary article about the conflicts of interest when doctors accept a meal, speaking fees, etc. from pharmaceutical manufacturers, along with a tally of the reported spend on state physicians, using data from public databases such as ProPublica. The doctor responded by acknowledging that yes, there have been issues, but those times are in the past. He went on to say that insurance companies have a bigger influence on what doctors write than any marketing ploy by a pharmaceutical company. He also defended the value of the relationship in that it keeps busy physicians up to date on new medications and therapies.

A report predicts the slowdown in FCPA enforcement actions in the first half of the year is only temporary and we can expect the DOJ to heat things back up the second half of the year. The report cites the unusual number of FCPA jury trials as the likely reason for the slow down.

State laws were on the hot seat this week as Maine’s legislature voted for the repeal of three of its reporting laws. The aptly named, An Act to Make Certain Prescription Drug Disclosure Laws Consistent with Federal Law, repealed Maine’s disclosure laws on marketing costs, prices of drugs subject to the Medicaid Drug Rebate Program and negative findings in clinical studies. In Vermont, a state auditor has tallied the cost of defending the state’s data mining law, which was recently declared unconstitutional by the Supreme Court. The auditor’s tally may be incomplete, as the court can still assign costs to the state as the losing party in the case. The auditor says the case could end up costing the state as much as $2 million.

We wrap up the news this week with a story involving the always hot button issue of off-label marketing. A California woman is suing Stryker and Medtronic, claiming the off-label marketing of their spinal fusion products has left her with debilitating injuries from excessive bone growth.

There are the hot topics in this week’s news. We’d like to take moment to remind you of our “hot of the press” new module, Good Promotional Practices. The module covers the essential topics for your commercial teams in a way that supports your values-based program. To learn more, please visit http://www.pharmacertify.com/commercial_compliance/good_promotional_practices.asp.

Whew! The mercury is still climbing as we wind it down and head for the weekend. Keep cool everyone, and we’ll see you back here next week.

The PharmaCertify™ Team

A 168 year old paper printed its last edition on Sunday, July 10. Another casualty of the Internet age? No, a casualty of an ethics breach so grave that it caused the paper to shut down. Of course we’re talking about the British tabloid, News of the World. We want to assure you, our dear readers, that we have not engaged in phone hacking or bribery here at PharmaCertify™ Week in Review. Okay, enough of that tangent and on to this (past) week’s news in review. It’s past because this one’s a little late. A big thank you to our readers who asked about this addition and alerted us that we had a problem! So, here we go.

Approved! The DOJ issued an advisory opinion regarding paying for trips of foreign officials. The agency cited previous guidance that approved payment for travel in certain circumstances where travel was acceptable, because it was used specifically to promote, demonstrate or explain the requesting companies’ offerings. The DOJ cautioned that this opinion did not represent a blanket approval for other companies in similar circumstances. Clear as mud. Thanks!

Caught on tape! Excessive hospitality provided by a pharma company during a medical congress in Spain. And that was just one of several companies cited in a Prescriptions Medicine Code of Practice Authority report. The hospitality in question was provided to healthcare workers from the UK’s National Health Service. Now these companies may find themselves being investigated by the Serious Fraud Office, under new powers granted to the organization through the UK Bribery Act.

Confession! A doctor relays his personal experiences with pharmaceutical sales representatives; from accepting a consulting offer that included a free trip to the unintended consequences of his decision to no longer see sales reps. The doctor also discusses current transparency efforts and the need for more regulation.

Violated! Canadian cosmetic surgeons have been warned that prescription drug information posted on their practice websites is considered marketing and is in violation of laws that prohibit the marketing of drugs to consumers.

Getting cozy! Cozying up to the pharmaceutical industry, Google may have solved some of the trepidation pharmaceutical companies face in embarking in social media. AstraZeneca raised concerns that the videos popping up in the suggestions column of the YouTube Channel they were developing were not ones they wanted associated with their brand. Google developed a feature through which channel owners with a certain number of videos can control what videos appear in the column.

Denied! The appeal of a compliance officer’s wrongful termination suit was denied by the 8^th Circuit Court of Appeals. The CO accuses her employer of having fired her over reporting concerns that the company was violating CMS requirements.

No Comment! Or comment if you feel so moved. The FDA is seeking public comments on its plan to remove a portion of PDMA regulations that require unauthorized distributors of drugs to provide the purchase history of the drugs they sell to their customers. The history, also known as a pedigree, traces the sale, and trade of drugs starting from the manufacturer through to the unauthorized distributor.

Enough! A panel of healthcare lawyers discussed the direction of health care fraud and enforcement at a forum hosted by Main Justice. One of the panelists commented that enforcement has moved from straightforward cases of wrongdoing to complicated cases where it is not even clear if items such as kickbacks were provided. They claim companies are subsequently having difficulty complying with the law.

Finished! Here we are at the end of another PharmaCertify™ Week in Review. But it isn’t the end of the compliance training tools we offer here at PharmaCertify. We’re here to help with your training needs on topics such as the FCPA, PDMA and the False Claims Act. Check us out at www.pharmacertify.com.

Keep cool!

The PharmaCertify™ Team

It is the end of an era, as the last space shuttle flight lifted off today at 11:29 EDT. In case you missed the launch, you can check it out here. Awesome sight, no? It’s time to launch into this week’s PC News Week in Review.

Despite a recent ruling to dismiss, a UK businessman says his False Claims lawsuit against Quest Diagnostics is “a go.” The man is accusing Quest of offering reduced pricing to insurance companies in exchange for government business, actions that resulted in inflated laboratory charges to the government to the tune of $1B.

A false claims whistleblower suit has caused the DOJ and several states to launch an investigation into a pain medication management company. The suit filed in a Massachusetts federal court alleges the company encouraged healthcare providers to either bill Medicare and Medicaid for services they did not receive or overbill for the service.

The difficulty of navigating cyberspace for pharma companies makes the news this week. Bayer has issued an apology for tweets that appeared on its UK Twitter feed. The tweets violated advertising regulations set forth by the Prescription Drug Medicines Code of Practice Authority. The primary issues were that the tweets did not appear to have been drafted by lawyers or compliance officers, and they promoted a drug to the public.

In the US, the director of DDMAC says that social media guidelines for the industry are the division’s top priority. Meanwhile, several of pharma’s heavy hitters filed a citizen’s petition with the FDA, requesting clarity around the issue of how to respond to unsolicited requests for off-label information. The petition could delay the release of the planned guidance document on the topic. The document is to include the topic of how to address the requests when they are received over the internet.

To twist a phrase from Jim Lovell – California, we have a problem. A state auditor has urged the governor of California to collect on the $355M in disputed drug rebates the state’s Medicaid program, Medi-Cal, is owed. A PhRMA spokesperson said disputes arise when states submit claims which aren’t in concert with the amount of drugs sent to wholesalers. Also, clerical errors contribute to disputes. The state’s pharmacy benefit chief said these disputes are complicated and take time to resolve. Complicating matters is a shortage of manpower to help resolve the disputes.

Minnesota’s Congressional contingent has joined in the blasting of the FDA for its drop in Investigational Device Exemption approvals. The lack of approvals is blamed for squelching innovation, the rash of new device companies closing or leaving the state and moving overseas. The FDA admits there is room for improvement on their end, however it is quick to point out that there is plenty of blame on the industry side as well. The agency claims companies submit applications with errors and propose poorly designed studies for their devices, which adds to the delay. Ouch. Maybe those involved should listen to the advice of this Minnesotan.

In a recent federal court case, a judge struck down a challenge to a Florida law that prohibits doctors from referring patients for lab work to companies in which they have a financial interest. The group that brought the suit claimed the FL law is pre-empted by the clinical services exemption in the federal Stark Law. The judge disagreed, saying there was no indication that Stark was meant to pre-empt state referral laws.

It was a no-go on a verdict in the infamous gun sting FCPA trial. After six votes, jurors in the case were unable to reach a verdict, and a mistrial was declared by the judge. The government says it will retry the case.

As we wrap up this edition of the News Week in Review, we’d just like to wish the final four astronauts of the shuttle program good luck and Godspeed on their mission. We’ll see you back here on earth July 20^th. Yes, you read that right. Atlantis is scheduled to return to earth on the anniversary date of man landing on the moon. The whole thing calls for a Tang toast don’t you think?

Have a great weekend everyone!

Independence Day… the day we celebrate the Shot Heard ‘Round the World with Fireworks. Yes, the quintessential American celebration is just a few days away! Before you start “rockin’ and a rollin’; splishing and a splashing” to celebrate all things America, kick off the weekend with this week’s News Week in Review.

While it may seem like a circus sometimes, our Three Ring Government was busy this week. Over in the Executive Branch, the FTC reached a $900,000 settlement with German company Beiersdorf AG, the makers of Nivea My Silhouette skin cream. The FTC charged that the company falsely advertised that regular use of the product would result in a reduction in body size.

In the judicial branch, the judge in the landmark Lindsey Manufacturing FCPA case has called into question the behavior of the government prosecutors. It seems prosecutors neglected to provide a transcript of grand jury testimony of an FBI agent to defense. The testimony is at the center of a defense motion to dismiss the indictment due to government misconduct. The judge said both parties should file new briefs regarding the dismissal of the convictions of the Lindsey defendants.

In other judicial news, questions were raised regarding the impact of the Supreme Court’s decision striking down Vermont’s data mining law. The technology website, Ars Technica questions if the decision will have an effect on behavioral advertising, like that used by Google. Likening the use of prescriber data in product detailing to the use of browser history data being used to feed ads while on line, Ars Technica questions whether the decision set precedent that using such data is not a privacy issue.

The legislative branch’s interest in Medtronic’s financial relationship with surgeons involved in clinical trials of the company’s spinal surgery product continues to make the news this week.

Since we are celebrating our nation’s independence, it is only appropriate that we give a nod to our friends across the pond. Seeking to advance the discussion of social media, the ABPI has issued a whitepaper and its own guidance around the handling of adverse events received through social media and company sponsored websites. This comes in advance of expectations of new government guidance regarding pharmacovigilance due in 2012. Well done! Necessity is the mother of invention.

The anti-corruption topic du jour has to be the implementation of the UK Anti-bribery on July 1. While companies scramble to prepare for the Act’s implementation, questions have been raised as to whether the Special Fraud Office (SFO) will have the funding needed to enforce the new law.

Finally we bring it back home to our own anti-corruption bill turned law, the FCPA. TrustLaw reports that at a recent conference on FCPA compliance, the topic of BRIC countries posing FCPA challenges was discussed. Each country has its own business environment challenges, which can lead to potential FCPA violations. Training and documenting that training was recommended for employees and contractors a company may have working in country. As it turns out, PharmaCertify can help you with just that.

That concludes our star-spangled edition of the PC News week in review. We the people of PharmaCertify hope you enjoyed the review this week. Now go out and fight for your right for some elbow room at the beach, barbeque, fireworks viewing or other festivity of your choice!

HaHave a safe and wonderful Independence Day!

Happy 235^th Birthday USA!