Anne McDonald Pritchett, PhD, senior vice president of policy and research at the Pharmaceutical Research and Manufacturers of America (PhRMA), said the industry is “poised to enhance the efficiency of drug development, improve predictability of reviews and help the FDA explore novel approaches to evaluating safety and efficacy of medicines, in order to accelerate the availability of new options for patients.”
During an executive forum at DCAT Week, Pritchett and other experts will discuss the current and future direction of product innovation in the pharmaceutical industry.
“We are in a new era of medicine where innovative treatment advances are transforming outcomes for patients,” Pritchett told us.
Options and access
There have been significant advances in the generic development and review process, said Pritchett.
“Generic drugs account for nearly 90% of all prescriptions filled and, in addition to spurring important market competition, offer patients needed treatment options,” she explained.
The US Food and Drug Administration (FDA) has also taken several steps to enhance the availability of generic drugs, including recently clearing the backlog of generic applications under review.
Pritchett said that PhRMA is supportive of “a robust biopharmaceutical marketplace” and the agency’s measures to increase generic availability.
“We are also focused on efforts to improve access and affordability for patients through market-based reforms that promote competition, modernize the drug discovery and development process, improve insurance affordability and move toward a system that prioritizes results for patients,” she said.
Additionally, while the industry needs to address challenges to insurance design and move to a system which rewards results, Pritchett said “we also must focus on ensuring an ecosystem that fosters innovation through robust intellectual property protection.”
IP and innovation
PhRMA filed its 2018 Special 301 submission last month. The annual Special 301 Report, which is required by the Trade Act of 1974, identifies a range of concerns that limit innovation and investment.
In its submission, PhRMA urged the Office of the United States Trade Representative (USTR) to take immediate action to address “serious market access and intellectual property barriers” in 19 overseas markets.
It also asked USTR to designate Canada, Korea, and Malaysia as “Priority Foreign Countries” – the designation for countries with “the most onerous and egregious intellectual property or market access practices that have the greatest impact on U.S. products,” according to PhRMA.
“IP is critical to continued medical innovation, enabling individuals and organizations to make the investments necessary to develop new medicines,” Pritchett said.
“PhRMA will continue to work with stakeholders to ensure strong intellectual property protections so our members can continue to bring the next round of innovation and cures.”