BIOCOM Releases Case Study on Use of Prescriber Data
On Monday, March 28, BIOCOM released a case study illustrating that, by tracking the use and side effects of a medicine, biotechnology companies can help physicians prescribe those medicines more safely and effectively. Safety First: The Role of Physician Level Data in Supporting Risk Evaluation and Mitigation Strategies (REMS) for Optimal Patient Care—A Case Study documents the use of physician level data by Amylin Pharmaceuticals (a BIOCOM member) in relation to SYMLIN, a life-changing medication for certain people with diabetes. Use of physician level data for SYMLIN is critical in meeting the Food and Drug Administration’s risk mitigation requirement. The report outlines how Amylin is using physician level data to:
• Negotiate with the FDA to determine which approaches and tactics were feasible
• Identify physicians skilled in the art of prescribing mealtime insulin—22,000 physicians from a universe of more than 400,000 health professionals who treat type 1 and type 2 diabetes
• Disseminate information and provide support for optimal patient care to selected physicians
• Monitor prescribing patterns on an ongoing basis to identify SYMLIN prescribers outside the original list and provide them with information and support
• Create ongoing dialogue with physicians regarding safety and appropriate use
Despite the benefits, some legislators have proposed measures in several states that would make this drug data unavailable.
“Many pharmaceutical and life science companies use physician level data, which by law cannot identify specific patients, to identify physicians for outreach and education efforts,” said Joe Panetta, President and CEO of BIOCOM. “This data allows these companies to deploy resources to physicians in a very targeted manner so that their patients receive the best monitoring and care standard,” Panetta said. “This report seeks to inform that conversation by giving a real world example of how a company worked with the FDA to develop a strategy using this information to maintain a high level of safety and efficacy for this drug,” he said.
DOE Loan Guarantee Program for Renewable Energy Projects Under Threat
The DOE loan guarantee program for renewable energy projects is under threat of being terminated by the US House of Representatives. BIOCOM opposes Sections 1425 and 3001 of the House Continuing Resolution (H.R. 1) which propose to terminate the Department of Energy's ("DOE") loan guarantee program for renewable and clean energy projects.
Should the loan guarantee program for clean and renewable energy projects be terminated, countless jobs would be lost and environmental benefits as well as America's ability to compete in the renewable energy field will be lost. In addition, California would be hard pressed to reach its Renewables Portfolio Standard benchmarks of 33% renewables by 2020, thus putting at risk the ability of California to meet its electrical needs.
By withdrawing the loan guarantee program, jobs, environmental benefits, and America's ability to compete in the renewable energy field going forward will be lost. Perhaps most importantly, these loan guarantees pave the way for greater American energy independence.
BIOCOM encourages you to voice your concerns over the anti-DOE loan guarantee provisions, so please consider calling your Representatives AS SOON AS POSSIBLE, and ask that Sections 1425 and 3001 of HR 1 are not included in the final House-Senate agreement on the continuing resolution. A list of representatives contact information is below. For more information contact Madeleine D. Baudoin, Associate Director of Public Policy.
Rep. Bono Mack
Rep. Bob Filner
Chairman Smith Releases House Alternative to Senate Patent Reform Bill
BIOCOM is pleased with the progress reflected by S. 23, as are industry supporters such as the Biotechnolgy Industry Organization (BIO), which applauded the legislation, saying it will "strengthen and improve our nation's patent system, spurring innovation and job creation".
House Judiciary Chairman Lamar Smith (R-Texas) introduced a companion bill in the House, entitled The America Invents Act, HR 1249 on Wednesday, March 30, 2011. Although much of HR 1249 incorporates favorable provisions of the Senate bill, BIOCOM members are concerned over several changes that were made, including language in Section 5 of Smith's bill related to inter partes review. The language in Chairman Smith's bill is troubling to BIOCOM members because it proposes to lower the threshold for initiating an inter partes evaluation at the USPTO.
Strong intellectual property protection is important to attract the substantial investment required to bring new life-saving therapeutics to the market. Toward that end, BIOCOM is pleased with the progress reflected by S. 23, and hopes as Chairman Smith's bill goes through committee and the full House that it maintains the same rigorous protections for innovators as provided in S. 23.
BIOCOM will remain very actively engaged on this issue, and looks forward to working with California members of the House Committee on the Judiciary as legislation moves forward. For more information contact Madeleine D. Baudoin, Associate Director of Public Policy.
BIOCOM Fights San Diego Housing Commission's Proposal to Increase Linkage Fees
As we have reported in past updates, BIOCOM has been a leader in a coalition opposed to a proposed linkage fee increase in the City of San Diego. Linkage fees are charged to businesses and developers that pull building permits and apply to new commercial or industrial additions and to interior remodeling that changes a structure’s use. The fees, charged on a per square foot basis, adversely affect businesses of every size that plan on building or remodeling facilities in San Diego. The fees collected go towards the City of San Diego’s Housing Trust Fund.
The San Diego Housing Commission has put forward a proposal to start increasing these fees as of 2013, and this plan includes a provision for an automatic escalator of 20% per year for 5 years, with an annual adjustment to be made thereafter. It should be noted that, in 1996, the San Diego City Council reduced the linkage fee by 50%, at that time believing the level of the fees was an impediment to business. The coalition opposing the SDHC proposal, including BIOCOM, has been meeting with Councilmembers and staff to emphasize the detrimental effect an increase in the linkage fees would cause.
The City Council's Land Use and Housing Committee was scheduled to hear this item on Wednesday, March 30, 2011.
Budget Talks Break Down, Governor Brown Mulls Options
After weeks of negotiations with Republicans failed to produce an agreement that would allow a ballot measure extending specific temporary tax increases, Governor Jerry Brown announced on Tuesday that he was halting such discussions. Both sides expressed frustration an agreement could not be reached.
On March 24, the Governor signed into law approximately $11.2 billion in budget cuts, but still faces a deficit of approximately $14.8 billion. A proposal to place a ballot measure before voters to extend temporary tax increases on sales, income and vehicle licenses has been the cornerstone to bridge that remaining gap, but Republicans in the Legislature have thus far declined to support placing the question before California voters. If a legislative measure is put to a popular vote by June 30, the threshold to pass continuation of the tax increases is a simple majority (50%+1). After that, the threshold becomes 2/3, which most observers feel is not viable given the current political and economic climate.
Other alternatives available to the Governor and Democrats in the Legislature include crafting a budget which addresses the deficit only through cuts, passing a budget (including the measures to put the tax extensions on the ballot) by a simple majority vote within very narrow parameters, or qualifying a citizen’s initiative for the ballot via signature collection. The simple majority vote option, which has been the subject of an opinion by the Legislative Counsel, is almost certain to be challenged in court, while qualifying a citizen’s initiative is extremely expensive.
BIOCOM will continue to monitor to constantly changing situation, and be prepared to engage when necessary. If you would like further information on this issue, please contact Jimmy Jackson at email@example.com.
Reminder for Companies with Hazardous Materials
Any company that generates, or stores hazardous materials must pay California’s environmental fee, and may also be subject to generator fees (if you generate >5 tons of hazardous waste per year). The fee is administered by the Department of Toxic Substance and provides funds for many of the DTSC programs. Businesses (and other organizations) pay these fees to the State Board of Equalization (BOE), in the form of an annual Return (as in tax!). The fee was established by State Senate Bill 475, 1989. Then expanded its scope in 2007, with SB 1803. There are many registrations, fees, and permits that a business must pay for the use, storage of hazardous material, and the generation of hazardous waste. It can be easy to think all your regulatory bases are covered, or that the agencies MUST communicate with one another to ensure that that your organization is complaint. Unfortunately this is not always the case; it is good idea to check a little further when you are unsure. The BOE registration is not always automatic with other registrations (or based on NAISC listing as some of the BOE information describes); a diligent business should contact the BOE regarding registration if they have never received an annual return.
This information is simply a reminder that you check on your BOE registration status…Why? Well, it’s the compliant thing to do, and the BOE has been auditing California businesses! So far (to my knowledge) only a small group of San Diego Biotech organizations have been hit with back fees, penalties, and interest. Hopefully this reminder will help keep that number low.
Please check out the BOE Special Tax – Environmental Fees site for more information.
Tom Evans, MS, CHMM, REA I
EHS Manager, Verenium Corporation