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!