Johnson & Johnson’s incoming CEO, Alex Gorsky, could be ordered to give sworn testimony in a Risperdal lawsuit, according to US government lawyers.

J&J has declined to make Gorsky available for a deposition in the case, which concerns the alleged payment of ‘kickbacks’ to health provider Omnicare.

The US government claims that millions of dollars paid by J&J to Omnicare as ‘market share rebates’ were inducements to buy and recommend Risperdal.

J&J claims that the rebates and the promotion of Risperdal were ‘common commercial practices’ that did not violate any law.

The case forms part of J&J's ongoing struggle to defend its marketing of the antipsychotic drug in the US against claims that it exaggerated the drug’s benefits and downplayed or concealed its risks.

Risperdal (risperidone) is approved as a treatment for schizophrenia and bipolar disorder in adults and behaviour problems in young people.

The company faces a cluster of lawsuits, both civil and criminal, based on allegations that it over-promoted the drug.

The US government has claimed that from 1999 to 2004, J&J gave Omnicare “market share rebate payments conditioned on Omnicare engaging in ‘active intervention’ programs for J&J drugs,” which it provided to nursing homes.

Gorsky succeeds Bill Weldon as CEO of J&J on April 26.

While with J&J subsidiary Janssen, Gorsky “was in a position to know why J&J chose not to inform Omnicare (or members of Janssen’s own sales staff) that, in January 1999, the FDA had warned J&J that marketing Risperdal as safe and effective in the elderly would be false and misleading,” the US filing stated.

Attorney Robert D. Keeling of Sidley & Austin, representing J&J, said that “Mr Gorsky has no reasonable connection to the subject matter of the government’s complaint,” and that the request for his testimony “unnecessarily targets – and thus would unduly harass – J&J’s top executive”.

Omnicare agreed in 2009 to pay $98m to settle civil claims by the US government and various states that it accepted kickbacks from J&J, but the company did not admit liability.

The new Bribery Act makes UK pharma companies legally responsible for any kickbacks their reps or distributors may offer to health officials anywhere in the world. Maxine Vaccine asks whether UK politicians who point the finger at traders can really be serious.

Compliance is the new CRM. In an era of globalised pharmaceutical trading, the UK Bribery Act and the US Foreign Corrupt Practices Act have sent a shock wave of pure terror through the industry. Basically, what the new legislation means is that a company is responsible what anyone acting on its behalf, even under contract, may do to advance its business. A local sales team or freelance distributor on the other side of the world might treat a village doctor to a bottle of whisky in return for a commission – and a biotech company in Cradley Heath might find itself fined out of existence. It’s scary.

According to a new Cegedim report 94% of life science companies now enforce corporate standards for spending on HCPs, while over half have a project team to address compliance issues. However, Cegedim warns that good intentions are not enough: without robust surveillance and reporting systems, those unmarked envelopes may slip through the cracks.

Closer to home, the ABPI Code of Conduct imposes very strict limits on the industry’s freebies and favours to its customers. Marcus Brigstocke raised some nervous laughter at last week’s Pf Awards by suggesting that pharma reps might moonlight as biro salesmen. The rules on hospitality threaten drug reps with wholesale loss of mates. Bourbons are completely banned. Only digestives are permitted, and they must be from Costcutters. In fact, you can offer branded biscuits only when selling generic drugs.

Compliance means more than just obeying those rules you know about in those transactions you personally carry out. You have to find out what all the relevant rules are and then apply them to every commercial interaction that touches your company. Being compliant takes proactive commitment, intelligence and good teamwork. Though when I put ‘Totally compliant’ on my Facebook profile I got some interesting messages.

So it was with some amusement that I read a recent newspaper story: the Conservative Party’s co-treasurer Peter Cruddas told undercover journalists posing as financiers that a minimum donation of £250,000 to Party coffers would gain them direct access to the PM’s policy unit. Make with the cash, he told them, and “things will open up for you”. In case they were unsure what that might be worth, he clarified the point: “It will be awesome for your business.”

Pardon my naive attitude, but WTF? The only part of ‘Foreign Corrupt Practices’ not implied by such promises is the word ‘Foreign’. Perhaps, before they legislate to rein in pharma industry reps, some of these politicians should look in the mirror.

It’s worth noting here that the private healthcare corporations currently in line for a share of the NHS franchise now the new Health Bill has become law are major donors to the Conservative Party, just as they were to Andrew Lansley’s campaign fund when he was Shadow Health Secretary. In addition, the BMJ reports that half of the doctors on the new CCG boards have financial interests in private healthcare companies that will be bidding to provide NHS services.

And meanwhile, we get stamped on for giving away a few biros. Are they having a laugh?

Maxine’s views are not necessarily those of Pharmaceutical Field.

Pfizer has agreed to pay over $60m to settle allegations that its sales executives paid bribes in order to secure the uptake of its products outside the US.

The pharma giant will make the payment by the end of 2011 in order to conclude federal investigations into its possible breaches of the US Foreign Corrupt Practices Act (FCPA).

The US Department of Justice (DoJ) and Securities & Exchange Commission (SEC) have recently investigated a number of pharma companies over alleged payment of bribes to foreign health officials to gain benefits such as the inclusion of drugs on formularies.

In April, Johnson & Johnson agreed to pay over $70m to settle charges that its operatives paid bribes to health officials in Greece and Iraq in return for medical device and drug orders.

The co-operation of Pfizer and J&J with US federal investigations has been credited with kick-starting an industry-wide crackdown on FCPA violations in countries where ‘informal payments’ may be common.

Following its acquisition of Pharmacia in 2003, Pfizer contacted the US authorities regarding evidence of improper payments made by executives of the company in Croatia.

Pfizer acquired Wyeth in 2009. In August this year, Pfizer said it had provided information to the DoJ and SEC regarding “potentially improper payments” made by Wyeth and Pfizer in “certain sales activities outside the US”.