Biotechnology companies and other stakeholders on Thursday applauded the government's new strategy to prepare the nation for biological threats.
"Serious deficiencies exist in the antibiotic and influenza vaccine and antiviral pipelines," said Robert Guidos, vice president of public policy and government relations with Infectious Diseases Society of America. IDSA is a national medical society representing physicians and scientists working with infectious diseases.
"HHS’s [Department of Health and Human Services] new initiative marks a recognition by the administration that current efforts and funding for scientific and research activities ... are not at the levels they need to be. Without a well-coordinated and strengthened federal approach to support development of countermeasures to treat, prevent and detect antibiotic-resistant bacterial infections, influenza and other infections, Americans will be at even greater risk from these threats in the future."
Anders Hedegaard, president and CEO of Bavarian Nordic, was also pleased. The Danish company recently delivered the first one million doses of a smallpox vaccine to the federal government.
"It was with great anticipation that I reviewed the Obama administration’s new plan for medical countermeasures against biological threats," Hedegaard said. "Today’s announcement that HHS will invest nearly $2 billion to streamline the regulatory process, augment manufacturing capacity and speed the development of novel technologies is a sign that the Obama Administration takes seriously this national security priority."
"We expect that new and dedicated funding to support the FDA’s regulation of medical countermeasures will simplify our efforts to overcome the regulatory challenges unique to medical countermeasures development," Hedegaard added.
"The report identifies the need for the U.S. government to do a better job at clearly articulating which products are needed, in what quantities. The development of an integrated 5-year budget for medical countermeasures development, procurement and stockpiling, and a clear articulation of the U.S. government’s requirements, will allow us to better target our investments in product development."