President-elect Obama begins to select administration members

The election of Barack Obama to become the next President of the United States at the start of November will potentially result in changes for the healthcare industry. Mr Obama had previously indicated his support for increasing access to generics as a means to reduce healthcare costs in the run up to the election, and on his www.change.gov website, the Obama-Biden Plan on healthcare reform includes plans to reduce costs for American families by, "Lower(ing) drug costs by allowing the importation of safe medicines from other developed countries, increasing the use of generic drugs in public programs, and taking on drug companies that block cheaper generic medicines from the market."

Not surprisingly, both the Generic Pharmaceutical Association (GPhA) and Pharmaceutical Research and Manufacturers of America (PhRMA) have congratulated Mr Obama on his election victory. Equally unsurprisingly, the GPhA has taken the opportunity to remind Mr Obama of his commitment towards increasing access to generics, adding that at the GPhA’s Annual Policy Conference in September, Mr Obama’s health policy advisor added that Mr Obama would also address issues including citizen petitions, free trade agreements and authorised generics as part of his healthcare agenda. The GPhA also added that the President-elect had also expressed support for biosimilars, noting that his campaign had stated that, as President, Mr Obama would support legislation to create a biosimilar approval pathway with as short an exclusivity period as possible to ensure timely consumer access. PhRMA had perhaps less to remind the President-elect of, but commented that the organisation would continue to work with lawmakers on both sides of the aisle and would continue to support policies that encourage and strengthen innovation, improve patient access to medicines and expand healthcare coverage.

Of course, Mr Obama’s administration is still taking shape, and the President-elect will not formally announce the administration until closer to his inauguration in January 2009. However, he has already apparently made a couple of appointments that will be of interest to the healthcare industry in general. Mr Obama has appointed Tom Daschle to be the new HHS Secretary. Mr Daschle, formerly a lawmaker for South Dakota, had been Democratic leader before losing his seat in the Senate in 2004. Mr Daschle had been an early supporter of Mr Obama.

Perhaps more interesting is news that Henry Waxman is to be appointed Chairman of the House Energy and Commerce Committee. PhRMA issued a statement on 20th November 2008 welcoming the chance to work with Mr Waxman, as it had also done for Mr Daschle the day before. However, it would be hard to imagine that PhRMA would have received this news with much enthusiasm. Mr Waxman, co-author of the Hatch-Waxman Act, has long been a supporter of the generic industry, although as the Hatch-Waxman Act has shown, he has been careful to balance this with considerations for the needs of the innovator industry. Mr Waxman has made no secret of his support for improving access to both generic and biosimilar medicines, and will now be chairing a committee that has oversight on healthcare issues. It will be interesting to see what the coming four or eight years will bring.

Ian Platts - Editor, World Generic Markets

Busy time for Actavis

The last month has been a busy time for Iceland’s Actavis, a firm which only a few weeks ago had to reassure the industry that it was protected from the crisis enveloping the Icelandic financial system. Towards the end of October, the firm announced that it was formally launching its presence in the French generics market, having been preparing the ground since 2007. Just a few days later the firm announced that it was expanding its presence in India by constructing new solid oral dosage facilities at its existing site in Alathur. The firm added that three construction projects were underway in India, and reported at the same time that it had inaugurated new laboratories at Ticel Bio Park in Chennai, India. Actavis’ physical presence was also boosted on 3rd November, with the news that the firm had opened new expansions to analytical and development laboratories to expand its R&D efforts in Florida.

Actavis has also announced plans to expand through alliances. On 30th October, the firm reported that it had entered into an exclusive distribution agreement for a number of generic products with J&M Pharma, a South Korean-owned and operated pharmaceutical firm. Actavis commented that this would be an important step in its plans to build its presence in the Korean market. A few weeks later, Actavis announced that it had concluded a preliminary agreement with ASKA Pharmaceutical, through which the two firms would establish a joint company through which Actavis could enter the Japanese generic market. Clearly, with the building work in India and the agreements in Korea and Japan, Actavis is looking to the Asia Pacific region to provide new sources of revenue.

Actavis has also been busy with product launches, announcing on 28th October that it had launched its atorvastatin product, Atacor, in Serbia. A few weeks later, on 13th November, the firm announced that it had launched its azithromycin product and Chlamydia testing kit in the United Kingdom.

However, for all these steps forward, Actavis has also found itself taking a step back. On 14th November, the US Department of Justice announced that the US was seeking a permanent injunction to bar Actavis Totowa and Actavis, as well as two of their leading officers, from the manufacture and distribution of generics until Actavis Totowa, the firm’s plant in New Jersey, was in compliance with Good Manufacturing Practices. Actavis Totowa, which had previously been the plant for Amide Pharmaceuticals before Actavis acquired the firm, has not had a good year, finding itself on the wrong side of a number of FDA inspections. The plant and Actavis has also found itself involved in congressional efforts to carry out an investigation into the plant, as part of oversight efforts regarding the FDA. Events came to a head after a batch of Actavis’ digoxin tablets from the plant were found to have double the stated dosage. Although Actavis has put the best spin it can on events, underlining its commitment to work with the FDA to resolve the issues and get the plant back on line, this must nonetheless be a disappointing end to an exciting few weeks for the firm.

Ian Platts - Editor, World Generic Markets