Articles Posted in Medical Countermeasures


influenza.jpegOn March 15, FDA announced the availability of a new guidance, Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products. The guidance is intended to encourage manufacturers of medically necessary drug products (“MNPs”) and their components to develop contingency plans for use when emergencies cause high absenteeism in their production facilities.

According to the guidance, a MNP is “Any drug that is used to treat or prevent a serious disease or medical condition for which there is no other adequately available drug product that is judged by medical staff to be an appropriate substitute.” FDA indicated that high absenteeism may be associated with the emergency situation for which the MNP is indicated, e.g., influenza pandemic, where widespread illness outbreaks could result in production stoppages.

by Brian J. Malkin

Reconstructed_Spanish_Flu_Virus.jpgOn August 19, the President’s Council of Advisors on Science and Technology (PCAST) recommended a targeted federal investment of $1 billion per year until certain key areas in flu vaccine development and production are improved to develop a more rapid response to flu outbreaks. Significant delays during the 2009-2010 H1N1 pandemic flu outbreak catalyzed the President to request this review.

PCAST’s report identifies five key areas that could lead to a faster response time: (1) surveillance – Centers for Disease Control to identify emerging pandemic viruses earlier, so vaccine production may begin earlier; (2) seed viruses – National Institutes of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA) to develop a collection of stock viral “backbones” to facilitate developing vaccine strains; (3) sterility testing – FDA and BARDA to develop faster and more reliable vaccine sterility tests; (4) potency test reagents FDA and BARDA to develop faster and more reliable vaccine potency tests; and (5) FDA and other federal agencies in collaboration with industry to enlarge capacity and modernize equipment used in final vaccine production including vial filling.


biohazard1.jpgOn August 19, Health and Human Services (HHS) Secretary Kathleen Sebelius announced a long-term plan to infuse $1.9 million into the public health infrastructure to help develop medical countermeasures to combat medical threats caused by both naturally-occurring and terrorism-driven events. Sebelius acknowledged that despite an increased awareness of new or potentially weaponized medical threats, the public health system has been slow to respond with new products and rapid manufacturing capabilities. For example, during a two-stage outbreak of H1N1 pandemic flu in 2009-2010, it took 26 weeks to develop the initial vaccine doses and 38-weeks to have sufficient doses for half of the population, when the second wave occurred already at 18 weeks.

HHS’s medical countermeasures focus on five key areas: (1) strengthening regulatory science at FDA, so it has the resources to create clear regulatory pathways and analyze new technologies faster by developing action teams for high priority products; (2) developing flexible manufacturing, so domestic facilities can change current manufacturing platforms to manufacture surge capacity for medical countermeasures; (3) utilizing the National Institutes of Health’s (NIH’s) resources to identify and nurture promising countermeasure technologies; (4) upgrading the current flu vaccine manufacturing process to include live attenuated strains, cell culture, and other technologies for more rapid vaccine development and production (see related blog); and (5) continue developing incentives for strategic partners to invest in new countermeasure technologies, such as more flexible contracting procedures.