LSIPR 50 2016: Barack Obama and Stephen Ostroff
Name: Barack Obama
Organisation: US government
Position: President
President Barack Obama is the 44th president of the US and was first elected in 2008. After being re-elected in 2012, he is serving his final term, which ends in January 2017. Obama was born in Hawaii in 1961 and moved to Chicago in the 1990s. He earned his law degree from the University of Chicago Law School, studying from 1992 to 1994.
One of Obama’s best known policies is his healthcare reform act, often called ‘Obamacare’. The law is officially called the Patient Protection and Affordable Care Act 2010. The aim of the bill is to enable Americans to afford better quality health insurance.
As a part of Obamacare in 2009, the administration signed into law the Biologics Price Competition and Innovation Act. This landmark piece of legislation provides a regulatory approval pathway for biosimilar products, but it was not until this year that the Food and Drug Administration approved the first biosimilar application, for Sandoz’s Zarxio (filgrastim-sndz), a biosimilar version of Amgen’s Neupogen (filgrastim).
In 2014, market intelligence company EvaluatePharma released a report called “World Preview 2014, outlook to 2020”, in which it discussed the impact of future patent expirations in the biological industry. It reported that from 2014 to 2020, “$250 billion of worldwide drug sales are at risk from patent expiries”. The consensus in the report was that biosimilar products will continue to have a “softer landing” post-patent expiry. It also commented that research and development is expected to grow at a “modest” rate of 2.4% a year from 2013 to 2020.
In 2015, the House Judiciary Committee voted to pass the Innovation Act. This bill, which aims to reduce litigation by so-called patent trolls, has yet to be passed by the Senate. Some commentators have criticised the bill by suggesting that it does not clearly distinguish between a patent troll and a genuine inventor and therefore would make it more difficult for individuals and small businesses legitimately to protect their intellectual property. Should this bill be enacted, it would be yet another example of IP-related legislation stemming from the Obama administration.
(Image: Everett Collection / Shutterstock.com)
Name: Stephen Ostroff
Organisation: US Food and Drug Administration
Position: Deputy commissioner for foods and veterinary medicine
Stephen Ostroff works as deputy commissioner for foods and veterinary medicine at the US Food and Drug Administration (FDA). He worked as the FDA’s chief scientist in 2014 and helped lead public health efforts. He graduated from the University of Pennsylvania School of Medicine in 1981 and then completed residencies in internal medicine at the University of Colorado Health Sciences Center.
In February 2016, Ostroff wrote an article on the FDA’s blog about Abbreviated New Drug Applications (ANDAs), discussing how the FDA was building a modern review process for generic drugs.
In it he said that the “generic drug sector has been enormously successful”, growing from 40% of drugs dispensed 20 years ago to 88% today. Approximately, $1.68 trillion has been saved because of this between 2005 to 2014, he said.
Ostroff added that the extra resources that the FDA agreed to three years ago in the Generic Drug User Fee Amendments (GDUFA), part of the Food and Drug Administration Safety and Innovation Act, which was passed by Congress in 2012, have helped increase the pace of ANDA approvals. The additional funding has helped the FDA hire and train more than 1,000 employees, develop an updated informatics platform to support the FDA’s review programme and re-organise the generic drug office, he explained.
Over the past few years, the FDA has approved “hundreds” of generics for more than 200 drug products by making “substantial” improvements such as including technical input from external organisations and experts, training review staff and enhancing their computer programmes to “streamline” the process, Ostroff wrote.
The ANDA backlog has also been cleared: in August 2014 there were “more than” 1,100 applications yet to be reviewed, but there is no backlog today, he said.
“All of us at the FDA are extremely proud of what we’ve accomplished in implementing GDUFA. In the first two years of the programme, we substantially enhanced our ANDA review programme. Now we’re cranking it up … More approved generics, if marketed, can further expand patient access to quality and affordable medicines,” he explained.
