Pharmaceuticals don't have a discovery problem, or a financing one, they have a political one that impedes everything else. Politics have a greater direct effect on the pharmaceutical industry than anything else in the US, and correspondingly drug companies makes considerable investments in election campaigns, just like unions and any other special interest reliant on government.
The November elections kept the face of Washington the same as 2010, with President Obama in the White House, Democrats still in control of the Senate and Republicans still controlling the House of Representatives - but that means the pharmaceutical industry will be impacted in a variety of ways.
The Medical Device Excise Tax, a component of the 2010 Affordable Care Act, survived a pre-election Congressional effort at repeal, but a coalition of House Republicans and Democrats from key states are looking to try again. Post-election, another bi-partisan congressional group is pushing for the FDA to impose stricter regulations on certain painkillers. Meanwhile, the Administration's prioritization of generics at the FDA remains controversial.
The budget impasse and resulting sequestration are election fall-outs that may impact the pharmaceutical industry in a number of ways: vaccines are the last goodwill remaining for the industry, due largely to exemption from nuisance lawsuits other drugs do not get, but those are likely to have decreased sales, if research funding is reduced it will also impact the private sector and any cuts at the FDA that could dramatically raise time to market. Medicare reform was also an unresolved issue that is going to be big in the next mid-term election.
The report "The Politics of Pharma" by Research and Markets provides an update and future outlook of how the political atmosphere within the United States will impact the pharmaceutical industry in both the near and long term, including:
- Current pharmaceutical related issues before the Supreme Court
- The impact of the November elections on the political issues that affect the industry
- As gun and abortion laws have shown, state politics will be increasingly important to pharmaceutical companies
- Implementation of The Sunshine Act and the meaningful use debate
- Biosimilar substitution
- Pay-for-delay, generics liability and off-label use court issue
Source: Research and Markets