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!