Generic Price-fixing Probe may See Progress

27.11.2019 -

Israeli generics giant Teva Pharmaceuticals and other generic drugmakers have been discussing possible settlements with US federal prosecutors in a long-running price-fixing probe. After six months there are signs the talks may finally be making progress, Bloomberg has reported.

A Teva representative is said to have told the news agency that the company is cooperating with the investigation and would be open to a deal that makes sense for shareholders and patients. 

Options on the table for all of the drugmakers are said to include deferred prosecution agreements, which could benefit both the federal government and the targeted companies. If criminal convictions bar generics makers from dealing with federal payers, there would be less competition for business with healthcare agencies Medicaid and Medicare, and generics prices would inevitably rise, the thinking goes.

Since the investigations began in 2016, the only settlements achieved were with a small generic drugmaker Heritage Pharmaceuticals, which included a $225,000 criminal penalty and a $7 million civil resolution.  As after that little or no progress was made, in June this year Democratic Party lawmakers pushed the US Justice Department to speed up the proceedings.

Teva is regarded as linchpin in the price-fixing momentum. Apart from the federal investigation, the Israeli firm and other generic drugmakers are potentially facing lawsuits from 48 US state attorneys general for gouging prices on hundreds of medicines over several years and are seen as eager to settle.  

Teva Reports Issues with Italian API Plant

Teva meanwhile is experiencing issues with its active pharmaceutical ingredient (API) plant in Italy and has had to stop production for an extended period. The generics specialist has told customers that it does not expect to restart the plat until at least January 2020.

Explaining the forced outage, Teva said it had been asked to submit new registration requests for products manufactured at the site, which, however, would be limited in scope and not require resubmission of the Drug Master Files.

Some market watchers blame the $3 billion annual cost-cutting scheme implemented by CEO Kåre Schultz, which has led to downsizing of manufacturing operations, for the problems.