CA Environmental Office Proposes Additional Labelling on Some Drugs and Medical Devices
The CA Office of Environmental Health Hazard Assessment held a meeting on Monday, April 14, 2014, regarding potential changes to the regulations applying Proposition 65. Included in the discussion was a proposal to potentially require California-specific Prop 65 warnings (pertinent to cancer and reproductive harm risks) on the packaging or package insert of FDA approved drugs and medical devices. Biocom was in attendance at this hearing, as were representatives of BayBio and some Biocom member companies.
This proposal to create California-specific labelling is of great concern to Biocom, and should be to any company with an approved drug or device. During her presentation, the Chief Counsel for OEHHA, Carol Monahan-Cummings, allowed that court rulings had consistently found FDA-approved packaging and package inserts provided sufficient warning for consumers, but that OEHHA staff still desired regulations requiring more detailed disclosure in many cases.
The CA Medical Assn, CA Dental Assn, and many others all challenged them on this point during the comment session, saying it would lead to significantly more litigation and possible patient confusion and unneeded alarm. After some detailed testimony on this point by a lobbyist who represents several Biocom member companies, the Director of OEHHA offered that a subgroup should be formed to discuss this individual issue separately. After the meeting, both Biocom and Baybio spoke to the Director offering to participate in any such subgroups.
Biocom will continue to monitor this process very closely. Public comment on the pre-regulatory proposal must be submitted by 5pm, May 14, 2014.
• Fact sheet Summarizing the Proposed Warning Regulation
• Draft Pre-Regulatory Initial Statement of Reasons for the Warning Regulation
• Draft Pre-regulatory Warning Regulation
• Side-by-side comparison of the existing regulations to the draft pre-regulatory proposal
Meeting presentation by staff
• OEHHA Presentation on Potential Regulatory Action
Biocom to Convene Meeting on Sorrento Valley Flooding
On April 24th, Biocom will host a meeting to provide an update on storm water channel maintenance in Sorrento Valley. In January 2013, the City of San Diego approved a Master Storm Water System Maintenance Program, which gave a five year allowance to do normal storm water maintenance in the coastal zone, including Sorrento Valley. A regular maintenance program and clearing of the concrete channels was scheduled to begin in fiscal year 2014. However, due to bird nesting in the channels and other concerns, maintenance was postponed.
The agenda for this meeting includes an overview of flooding impacts to businesses, an update from the City of San Diego regarding channel clearing, and an update on flooding and water quality in the Los Peñasquitos Watershed. The meeting will be of particular interest to Biocom members located on Roselle Street and elsewhere in Sorrento Valley that have been impacted by flooding in the past.
The meeting will occur on Thursday, April 24 at Biocom from 11:30am until 1:30pm. Lunch will be provided. If you are interested in attending the meeting, please contact Melanie Nally, Associate Director of Local Government & Regulatory Affairs at firstname.lastname@example.org or 858-455-0300 x113.
Biocom Participates in BIO Fly-In and PhRMA Annual Meeting
Last week, Biocom traveled to Washington DC to attend the BIO Fly-In and PhRMA’s Annual Meeting.
As part of the BIO Fly-In, Biocom joined hundreds of life science companies and organizations from California and all across the country to represent the needs of our industry before Congress. Biocom met with Senators, Members of Congress, and their staff to discuss some of the most pressing issues the industry is facing. In particular, Biocom urged Congress to allocate additional funding for NIH and FDA in Fiscal Year 2015 spending measures, ensure that FDA user fees are not sequestered in the future, and maintain funding levels for biorenewable programs. Biocom also advocated against any further cuts to Medicare Part B drugs and changes to the Medicare Part D program, which encounters a 90 percent satisfaction rate among beneficiaries. Lastly, Biocom warned against any patent litigation reforms that would make it more difficult for patent holders to assert their patent rights and consequently harm our innovation system.
Biocom also attended PhRMA 2014 Annual Meeting and met with business leaders, policymakers, industry experts, and patient groups to discuss the state of science and health in 2014 and beyond. FDA Commissioner Margaret Hamburg commented on FDA’s latest activities and initiatives.
CBER IS MOVING
In an effort to consolidate, FDA is moving the offices and laboratories of the Center for Biologics Evaluation and Research (CBER) from their present locations in Bethesda and Rockville, Maryland to the FDA White Oak campus in Silver Spring, Maryland. Most offices will commence moving on or about April 25, 2014, and will complete the move approximately five weeks later, on or about May 18, 2014. Laboratories and remaining offices are scheduled to move in late June through August. In order to facilitate continuity of operations, one division, the Division of Biological Standards and Quality Control, within the Office of Compliance and Biologics Quality, will remain in its present location at 5516 Nicholson Lane, Building B, Kensington Md. 20895 and move after processes assuring the availability of 2014-2015 seasonal influenza virus vaccine are completed.
Lifeguard Ed Harris Appointed to Vacant San Diego City Council District 2 Seat
On April 7th, the San Diego City Council appointed Ed Harris to serve out the remaining eight months of Kevin Faulconer’s term for Council District 2. Harris is a retired marine and longtime San Diego lifeguard, who heads the city’s lifeguard union. District 2 includes coastal communities from Point Loma to Bay Park, and Harris has said he will advocate for upgrades to these communities including crosswalks and clean beaches. Harris’ past civic engagement includes support of a movable barrier to separate people from seals at La Jolla Cove, and negotiating a deal with Toyota for naming rights to lifeguard vehicles, which he says brought the city $1.1 million.
Harris’ nomination gives the Democrats a 6-3 veto-proof majority on the Council. Harris will serve as District 2’s representative until December; he is prohibited by the City’s charter from running for election to the seat. He was chosen out of a pool of 17 candidates, and received votes from Councilmembers Zapf, Kersey, Sherman, Lightner, and Alvarez. In June, current Councilmember Lorie Zapf will be running for election in District 2 due to redistricting, with a possible runoff in November. Zapf and candidates Sarah Boot, Jim Morrison and Mark Schwartz will attempt to secure a majority vote in the primary; if no candidate recieves a majority the top two candidates advance to the runoff.