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BIOCOM ::

BIOCOM Federal Update

Several bills of interest to the life science industry are being fast-tracked in both the House and the Senate:

Track &Trace

The House and Senate have released two bills (House bill, Senate bill) that would establish lot-level product tracing requirements for manufacturers, wholesalers, pharmacies, repackagers, and third-party logistics providers. The Senate bill goes further by requiring that a unit-level tracing system be put in place within 10 years. Both bills would pre-empt state laws at the time of enactment, including California’s law. Several Members of Congress are pressing for not pre-empting state laws until Federal regulations are fully implemented, which would require that all members of California’s supply chain invest resources to comply with two systems. BIOCOM is advocating for pre-emption at the time of enactment.

On May 15, the Energy and Commerce Committee approved the bill by voice vote. The Senate Health, Education, Labor, and Pensions (HELP) Committee is scheduled to markup its bill on May 22. The bills may be on the House and Senate floors before the Memorial Day recess.

ADUFA/AGDUFA

On May 15, the Energy and Commerce Committee also approved, by voice vote, a bill (H.R. 1407) that would reauthorize animal brand-name and generic drugs user fees. The current authorization expires on October 1, 2013. The bill may be on the floor before the Memorial Day recess. The Senate already passed its own reauthorization (S. 622) on May 8.

Compounding

The Senate released a draft that would give the FDA the authority to regulate non-traditional compounding pharmacies, which make sterile products without or in advance of a prescription and sell those products across state lines. The bill would establish a uniform set of regulations for compounding manufacturers, while maintaining states’ oversight over traditional compounding pharmacies. The Senate HELP Committee held a hearing on the bill on May 9, and is scheduled to markup the bill on May 22.

Farm bills

The House and Senate Agriculture Committees released their respective drafts of the “farm bill” (House draft, Senate draft) last week. BIOCOM supports final products that include mandatory funding for the Energy Title programs, such as renewable chemicals, biobased products, and advanced biofuels. Both bills were successfully marked up this week and may come to the floor before the Memorial Day recess.

Immigration reform

The Senate Judiciary Committee has begun consideringa bipartisan immigration bill (S. 744) this week. The bill increases the annual number of H1-B visas available. The Sponsors’ Amendment, which updated the original bill, sets aside 25,000 visas for aliens with STEM degrees, including life science degrees.  BIOCOM advocated for the inclusion of these degrees.

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Governor Proposes To Exempt Biotech Research and Development Equipment From State Sales Tax

On Wednesday, May, 15, Governor Jerry Brown released the May Revision to his 2013-14 budget proposal.  One aspect specific to the life science industry is the Governor’s proposal to make a tremendous change to the enterprise zone program.  The May Revise proposes to take a portion of the money now used for enterprise zone credits and instead create a sales tax exemption for equipment used in manufacturing or “biotech research and development”  (language used in the Governor’s office’s Fact Sheet on the proposal).

California is one of only three states which charges sales tax on manufacturing equipment, which by definition creates jobs.  BIOCOM has long argued that the same can be said for equipment used in research and development in the life science industry, and that these positions are high wage, environmentally friendly jobs that the state should encourage.   The Governor's proposal seems to indicate agreement with this position, although specifics are not known at this time. BIOCOM will monitor and engage on this proposal as legislative language is published and it starts through the budget process.

BIOCOM’s Sacramento contract lobbying firm, Sloat Higgins Jensen and Associates, has written this summary on the Governor’s entire May Revision proposal.  A complete summary of bills BIOCOM has established a position on can be found here.  Please stay tuned to the BCQ for further details as they develop.

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