Public Policy News

Biocom Holds Successful Water Workshop

On April 22nd, Biocom held a Water Workshop to share information with our members about the drought situation in California, upcoming regulations to address the water shortage, commercial water systems, and water savings rebate programs. Speakers from the Metropolitan Water District of Southern California (MWD) and the San Diego County Water Authority painted a dreary picture of current conditions, with the snowpack in the Sierras being the lowest ever recorded in 2015. They emphasized that drought conditions have been worsening for the past seven years, and water agencies have been diversifying their water portfolios even before that to anticipate shortages and strengthen reserves.

Agencies from the state to local level have been issuing cutback targets to respond to drought conditions. Governor Brown released his 25% cutback target on April 1st, and MWD adopted a 15% cut on April 14th. The State Water Resources Control Board responded to the Governor's target by issuing targets for each local water agency, which were revised on April 18th. This includes a 16% reduction for the City of San Diego. Luis Generoso, Water Resources Manager at the City of San Diego, reviewed the city's current mandatory restrictions at the workshop, including residential restrictions on watering lawns and driveways, serving water at restaurants only on request, and using recirculated water for ornamental fountains. In addition to these permanent restrictions, the city plans to issue guidelines to further restrict watering lawns, washing vehicles, and irrigation. To meet the cutback target, the city plans to step up enforcement measures, increase its turf rebate program, stop watering medians, and reduce watering at some city parks. The city's Waste No Water campaign seeks to inform consumers about current regulations and encourage voluntary compliance.

John Wammes with Water Works, Inc. shared innovative water systems that his company has recently installed at several life science companies, including Thermo Fisher Scientific and Pacira Pharmaceuticals. These projects can generate additional millions of gallons of reusable water while also reducing waste and saving money. Finally, Bill McDonnell shared MWD's rebate programs for commercial water efficiency upgrades. MWD offers extensive rebates for a wide range of conservation systems, including landscape controllers and nozzles, plumbing, HVAC, food service, and health care. Their water programs can be found at www.bewaterwise.com.

The workshop was attended by over 60 Biocom member companies, exceeding usual workshop attendance. The timeliness of this issue proved to attract a crowd, and member feedback from the event was positive. For more information about the workshop, upcoming regulations, and rebate programs for businesses, please contact Melanie Nally at mnally@biocom.org or 858-455-0300 x113.

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Biocom Weighs In on Patent Litigation Reform

As Congressional Committees start to consider several legislative proposals that would make changes to our patent system, Biocom continues to be engaged in the discussions.

Last week, Biocom submitted a statement to House Judiciary Committee Chairman Bob Goodlatte expressing concerns with H.R.9, the so-called Innovation Act. The bill aims at curbing patent trolls' abusive litigation practices but would do so by making it more difficult, expensive, and lengthy for inventors to enforce their intellectual property rights and defend themselves against infringers, which would in turn devaluate patents. The statement was included in the record by Congressman Scott Peters (D-San Diego) during the April 14th hearing on the bill. Click here to view the statement.

In addition, earlier this week, Biocom, along with BayBio and the California Healthcare Institute, submitted a letter to the House Energy & Commerce Committee in support of the Targeting Rogue and Opaque Letters (TROL) Act, ahead of the April 22nd subcommittee markup of the bill. The bill specifically targets deceptive and abusive mass mailings of demand letters, while allowing legitimate patent owners acting in good faith to continue sending business-related communications to alleged infringers. Click here to view the statement.

Biocom will continue to work with Committee staff and the California delegation to ensure that the constitutionally-protected rights of patent owners are preserved.

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California Legislature Rolls Toward Deadline

The state legislature is now working at a feverish pace to meet its next legislative deadline. All bills must pass their first policy committee by May 1st.. Because all bills introduced must meet this deadline, this is one of the busiest times of year for the state legislature.

In legislative action since the last BCQ, Assembly Bill (AB) 437, authored by Assembly Speaker Toni Atkins of San Diego which would allow monetization of accrued state Research & Development (R&D) income tax credits, was heard in the Assembly Revenue and Taxation Committee on Monday, April 20. Biocom and CHI testified in favor of the bill, which despite minor opposition was put into the Committee's "suspense" file, a holding place for alleged high cost legislation until the state budget is resolved. Biocom will continue to lobby aggressively on this important legislation.

In one of the most aggressive bills adversely targeting the life science industry in years, AB 463 (Chiu, D-San Francisco) would require innovators to publicly disclose an incredible amount of proprietary information, including:

(1) The total costs for the production of the drug, including all of the following:
(A) The total research and development costs paid by the manufacturer, and separately, the total research and development costs paid by any predecessor in the development of the drug.
(B) The total costs of clinical trials and other regulatory costs paid by the manufacturer, and separately, the total costs of clinical trials and other regulatory costs paid by any predecessor in the development of the drug.
(C) The total costs for materials, manufacturing, and administration attributable to the drug.
(D) The total costs paid by any entity other than the manufacturer or predecessor for research and development, including any amount from federal, state, or other governmental programs or any form of subsidies, grants, or other support.
(E) Any other costs to acquire the drug, including costs for the purchase of patents, licensing or acquisition of any corporate entity owning any rights to the drug while in development, or all of these.
(F) The total marketing and advertising costs for the promotion of the drug directly to consumers, including, but not limited to, costs associated with direct to consumer coupons and amount redeemed, total marketing and advertising costs for promotion of the drug directly or indirectly to prescribers, and any other advertising for the drug.
(2) A cumulative annual history of average wholesale price (AWP) and WAC increases for the drug (expressed as percentages), including the months each increase in each category, AWP and WAC, took effect.
(3) The total profit attributable to the drug as represented in total dollars and represented as a percentage of the total company profits that were derived from the sale of the drug.
(4) The total amount of financial assistance the manufacturer has provided through patient prescription assistance programs, if available.

Life science companies, associations (Biocom, BIO, PhRMA and CHI), and business groups such as TechNet who recognize the dangerous precedent this bill would set, conducted an intense education drive with legislators to combat falsehoods spread by the health plans trying to justify the bill. As the April 21st Health Committee hearing developed, the author realized he would not be able to secure the votes to pass the bill at that time, so he withdrew it from consideration before a vote was taken, but the bill can be taken up at a future date. Biocom thanks Assemblymembers Rocky Chavez, Brian Maienschein and Marie Waldron for speaking publicly against the bill during its hearing, and Assemblywoman Lorena Gonzalez for making her opposition to the bill known before the hearing. All San Diegans on the committee stood firm in their support of the industry.

Many other bills are being heard in the next two weeks. A comprehensive list of Biocom's bill positions can be found here.

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Biocom Files Testimony on Medical Device Tax

Ahead of today's Congressional hearing "A Fresh Look at the Impact of the Medical Device Tax on Jobs, Innovation, and Patients," Biocom submitted a statement expressing our concerns with the medical device excise tax and supporting its full repeal. The tax, which took effect in January 2013, is expected to cost medical device manufacturers $30 billion over the next 10 years, stifling R&D investments, hampering job creation, and jeopardizing patient access to breakthrough devices and therapies.

The hearing is held on April 23rd at the Senate Finance Subcommittee on Health Care. Senators will have the opportunity to hear from and question several witnesses from medical device manufacturer to patient. This is the first hearing dedicated to evaluating the impact of the tax since its implementation.

Click here to view Biocom's statement.

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Biocom Participates in BIO Fly-In

Last week, Biocom traveled to Washington D.C. to attend the BIO Legislative Fly-In. Biocom joined hundreds of life science companies and organizations from California and all across the country to meet with Members of Congress and their staff, and discuss some of the most pressing issues the industry is facing.

In particular, Biocom presented the strengths and challenges of our Southern California life science community, stressed the importance of providing adequate funding for the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), discussed drug development and delivery reforms, and warned against patent litigation legislation that would harm our innovation ecosystem by making it more difficult and expensive for patent holders to assert their patent rights.

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