Policymakers are devising "pro-innovative" approaches for testing and regulating medical products amidst the clamor to curb
the cost and time of drug development and thus speed more new products to patients. A lead strategy for the White House, Congress,
and the biopharmaceutical industry is to portray the development of new biotech therapies as key to driving US economic growth
and creating high-wage, high-value jobs, desired by every state and nation.
In pressing for fast approval of legislation to reauthorize user fees for FDA, House Republicans highlighted how improvements
in the biopharmaceutical regulatory process will promote American innovation and jobs growth. Legislators on all sides agreed
that more predictability, consistency, and transparency in drug oversight help stem the shift in jobs overseas and ensure
patient access to innovative therapies.
Biotech manufacturers also stand to gain from an effort in Congress to revive tax credits and grants for emerging companies.
A small provision in the 2010 healthcare reform legislation provided $1 billion to support biotech firms investing in R&D,
and the Biotechnology Industry Organization is pressing for a second round. Sen. Robert Menendez (D-NJ) recently introduced
a bill (S.3232) to provide $1 billion to extend the "therapeutic discovery project program" for two years, but tight federal
budgets may make it much harder to find the money this time around.
Legislative efforts to promote biopharmaceutical innovation should gain support from the national "Bioeconomy Blueprint,"
issued in April by the White House Office of Science and Technology Policy (OSTP) to promote economic growth while improving
public health. The report proposes multiple strategies for encouraging innovation in the biological sciences, from genetically
engineered crops and bio-based fuels to next-generation biomanufacturing methods and regulatory reform. The report states
that these strategies would foster a "robust" biomedical research enterprise able to speed drug development and harness biology
as a manufacturing platform for rapid production of new high-value materials, medicines, devices, and fuels. The administration
says it's serious about reducing regulatory barriers to increase the speed and predictability of processes for bringing new
biotech products to market.
The blueprint specifically backs research to advance pluripotent cell technology, to validate promising drug targets, and
to establish standards that can improve protein-manufacturing processes. Multiple federal agencies are involved, such as the
National Institute for Standards and Technology (NIST), which is working with FDA on measurements that can more accurately
characterize key safety and efficacy attributes of proteins. The Department of Defense is developing more flexible and rapid
biotech manufacturing platforms, and the National Science Foundation is investing in biomanufacturing approaches for advanced
tissue engineering and flexible bioelectronics.
In unveiling the blueprint, the White House highlighted potential gains from expanded use of FDA's vast repository of clinical
data, including safety, efficacy, and performance information from clinical trials and a growing volume of post-market safety
data. Analyzing information could "revolutionize the development of new patient treatments" and address fundamental questions
relevant to development of personalized medicine. Biomanufacturing will be enhanced by FDA efforts to rebuild its information
technology and data analytic capabilities and to establish "science enclaves" where multi-disciplinary teams can analyze large
sets of data extracted from FDA resources to speed the development of new therapies at reduced cost. Although many of the
"new" initiatives described in the report are well underway, they stand to gain from the administration's explicit statement
in support of the long-term economic importance of biotech research.