The new law also calls for support for emergency medicine research including pediatric emergencies.
In addition, an Office of Women’s Health and Gender-Based Research will be established to develop research goals for issues that affect women’s health and to develop “evidence reports and clinical practice protocols and conduct research into patient outcomes, delivery of healthcare services, quality of care, and access to healthcare.”
Pain research and pain management research are also expected to expand under the Pain Consortium of the NIH. A pain research coordinating committee will be developed.
The law, in section 4204, gives the Secretary of HHS the authority to negotiate directly with drug manufacturers for the purchase of childhood, adolescent, and adult vaccines. States will be given the ability to obtain additional vaccines at that negotiated price. Under that scenario, it seems that the government will soon become the primary—if not the sole—customer for vaccines. Consequences may include driving the price down, which may have ramifications for further vaccine development both in terms of funds available and the nature of the vaccines developed.
The Secretary of HHS will also determine the advisability of a standardized format for presenting the risks and benefits of individual prescription drugs on their labeling and advertising.
The healthcare reform bill also creates a $1 billion therapeutic discovery project tax credit focused on companies with fewer than 250 employees. According to Collar, “80 percent of biotech companies are in this category.” Jeff Joseph, BIO spokesman, further explained that this tax credit will help offset expenses on therapeutic development such as hiring scientists and conducting clinical studies. “The economic crisis hit small biotechs hard, shutting down some projects,” Joseph added.
That being said, if those funds were spread evenly among the approximately 1,400 U.S. biotech companies, they would amount to about $700,000 each—not much when it takes about $600 million to bring a drug to market. It may be enough, however, to help some companies weather the economic storms.
According to Joe Panetta, president and CEO of Biocom, “insurance rates will go through the roof,” as a result of enactment of H.R. 3590. In response, some of Biocom’s members are exploring the idea of creating company clinics or becoming self-insured. There is concern among many businesses that paying higher health insurance fees will divert funds that otherwise would be used for investments.
Panetta called government involvement in healthcare and healthcare insurance a “slippery slope” that attracts ever more government involvement. It is likely, as lawmakers on both sides of the aisle have promised that, “this won’t be the end of it.”