Issues and Achievements

Issues and Achievements

2017 Priority: Improved & Expanded NIH SBIR Program

The SBBC has engaged the Trump Transition Team and members of Congress and their staff to explore an array of new NIH initiatives to help small businesses more rapidly advance their products to the clinic, with less cost and risk to our shareholders. These initiatives include more small business involvement in setting funding priorities and practices, including, but not limited to the SBIR program.

CLICK TO DOWNLOAD COMMERCIALIZATION ADVISORY COUNCIL WHITE PAPER

In 2015 we surveyed the NIH SBIR community and found that there is consensus about the need for reforms to the NIH SBIR program. Survey Results

Previous Victories & Accomplishments

SBBC was established in 2010 following the exclusion of the SBIR allocation from the $10 billion NIH “Stimulus” funding increase. This was a result of a clandestine, 11th hour efforts by enemies of the NIH SBIR program. A small group of Maryland based biotech CEOs mobilized and convinced Senator Ben Cardin (D-Md.) to hold a field hearings on the topic in Rockville, MD. As a result of this effort, at least part of the NIH Stimulus was used to support SBIR grants and contracts.

In 2011 SBBC led the successful legislative effort to increase the SBIR allocation from 2.5% to 3.2% of R&D grants from the NIH and other federal agencies. This was the first increase in the SBIR allocation in more than 20 years and was strongly opposed by dozens or organizations and agencies including the White House and the universities and medical colleges. SBBC was the only biotechnology organization that lobbied in support of the allocation increase. Click to download SBIR allocation open letter.

In April 2012 Congress passed the historic SBBC supported JOBS Act ushering the most important changes to U.S. Securities laws since the 1930s. In August 2012 SBBC, working with the NSBA, organized a meeting between several small biotech company CEOs and senior staff from the Securities and Exchange Commission (SEC). The meeting focused on how SEC should implement Title II of the JOBS Act provision eliminating the prohibition against general solicitation and general advertising in private placements made under Rule 506 of Regulation D. Ours is believed to have been the only meeting that the SEC had with biotech CEOs to discuss this fundraising approach. This provision allows our companies to use the internet or press releases to identify accredited investors interested in the diseases which we are addressing. As seen from the attached letter that followed we cautioned against burdensome requirements to verify the accreditation status of investor. Click to download SEC open letter.

On July 10, 2013, the SEC adopted a rule largely in line with the suggestions of SBBC. Businesses will be required to take “reasonable steps” to ensure that investors are accredited investors. The new rule provides a “non-exclusive” list of what constitutes reasonable steps to verify the status of an investor as an accredited investor. Supporting Diagnostic Innovation by Small Companies

In 2015 the FDA issued draft guidance to regulate laboratory developed tests (LDTs). The SBBC lobbied both the FDA and Members of Congress to protect innovative diagnostics tests that address unmet medical needs

from excessive and unpredictable regulation. We have also created a transferable priority review voucher program that would significantly drive equity investments into small diagnostics businesses that do not generate investment interest due to low reimbursement levels. CLICK TO DOWNLOAD DIAGNOSTICS LEGISLATIVE PROPOSAL

In November 2016 the FDA announced that it was suspending its plans to regulate LDTs.