A Senate committee approved the Biodefense and Pandemic Vaccine and Drug Development Act, sponsored by Sen. Richard Burr, R-N.C. The Senate Health, Education, Labor and Pensions Committee approved the bill by a voice vote and now the bill goes before the full Senate.
Key components of the Biodefense and Pandemic Vaccine and Drug Development Act include:
Establish a single agency – the Biomedical Advanced Research and Development Agency (or BARDA) – as the lead federal agency for the development of countermeasures against bioterrorism. The new agency would report directly to the Secretary of Health and Human Services.
Provide incentives for domestic manufacturing of vaccines and countermeasures.
Give liability protections to companies that develop vaccines for biological weapons.
However, the bill is noteworthy for what is not included. Some expressed concern that the bill does not take up the threat of a pandemic sparked by the spread of avian flu. Others felt that it is the best solution at the moment because so many variables are involved.
The bill also extends some prescription drug patents. However, the extensions have been criticized by some organizations who fear that they would block more affordable generic drugs. For instance, the bill would allow Health and Human Services to sign exclusive sales contracts with particular manufacturers for a particular product. It would forbid government purchases of generic versions of such new drugs or vaccines as well as public sales of the products for use as countermeasures.
The bill is opposed by the Coalition for a Competitive Pharmaceutical Market, which believes that the market exclusivity provisions would unnecessarily drive up prescription drug costs for private and public payers without advancing our nation’s bioterrorism preparedness.
The drug monopoly extensions included in S. 1873 would broaden the definition of products eligible to be used as countermeasures in a way that could grant existing everyday medicines – rather than novel products related to the fight against bioterrorism – multiple years of additional market exclusivity.
Liability protection was also a key concern in order to protect consumers from vaccines and countermeasures that proved harmful. The measure states that a manufacturer, distibutor, or administrator of a security countermeasure, or a qualified pandemic and epidemic product or a health care provider shall be immune from suit or liability caused by or arising out of the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescribing, administration, or use of a security countermeasure, or a qualified pandemic and epidemic product. The liability provision was added immediately before the bill was introduced, but does have a clause dealing with producers that knowingly manufacture a bad drug.
It does not contain the earlier provision for the wild card extension (transferable intellectual property rights) for drugs with qualifying biodefense capabilities. For example, if the wildcard is 2 years, and an antibiotic is approved for BioShield II purposes, then the drug company could transfer 24 additional months of patent protection to any drug in its portfolio (e.g., blockbuster drugs like Viagra or Lipitor).
If a drug company needs a reward for the bioterrorism innovation, the more direct way to do so would be to pay a premium when purchasing the drug. The wild card system is less efficient than a contractual premium because the incentive varies with the portfolio of the company: if you are Pfizer the wild card is worth more than it would be to a smaller pharma or biotech company. The wildcard would operate as a tax on a wide population who pays for (now extended patent coverd) treatment.
