Posts Tagged ‘FDA’« Older Entries
The Definitive Forum on the Legal, Regulatory, and Commercial Realities of Biosimilars
Drawing on 3 years of top-notch programming, ACI’s 4th Annual Biosimilars program remains the industry’s leading legal and regulatory event. Check this interesting retrospective slide.
When: Wednesday, June 26 to Thursday, June 27, 2013
Where: Chicago-Mart Plaza (Riverview) Hotel, Chicago, IL
For more information, and to register: click here
Industry related article from Examiner.com, by Mary Schwager, posted on 05/07/13:
Williams-Sonoma fined for failure to report defects in Pottery Barn products
Williams-Sonoma: BUSTED! The retailer is dishing out nearly a million dollars to pay a civil penalty to the Feds for failing to report product safety defects it knew about. Companies are supposed to report any defects, product failures or people injured by defective merchandise to the US Consumer Product Safety Commission ASAP. Looks like the company didn’t follow that ASAP part.
The defective product is a hammock stand made by Pottery Barn, a company owned by Williams-Sonoma. Here’s a link to the original recall in case you have one in your backyard.
The CPSC put out a news release today saying:
Williams-Sonoma, Inc., of San Francisco, Calif., has agreed to pay a $987,500 civil penalty.
In addition to paying a monetary penalty, Williams-Sonoma has agreed to implement and maintain a compliance program designed to ensure compliance with the safety statutes and regulations enforced by the Commission. Williams-Sonoma has also agreed to maintain and enforce a system of internal controls and procedures designed to ensure that:
Information required to be disclosed by the firm to the Commission is recorded, processed, and reported, in accordance with applicable law;
All reporting made to the Commission is timely, truthful, complete, and accurate; and
Prompt disclosure is made to Williams-Sonoma’s management of any significant deficiencies or material weaknesses in the design or operation of such internal controls that are reasonably likely to adversely affect, in any material respect, the company’s ability to report to the Commission.
Williams-Sonoma further agreed to provide written documentation of such improvements, processes, and controls, upon request of CPSC staff; to cooperate fully and truthfully with CPSC staff; and to make available all information, materials, and personnel deemed necessary to staff to evaluate the company’s compliance with the terms of the agreement.
The settlement resolves CPSC staff’s charges that the firm knowingly failed to report to CPSC immediately, as required by federal law, a defect involving Pottery Barn wooden hammock stands. Williams-Sonoma imported the wooden hammock stands between March 2003 and July 2008, and distributed them exclusively through Pottery Barn and PBteen catalogs and websites, and Pottery Barn Outlet stores. The hammock stands were sold nationwide for approximately $300.
CPSC staff alleged that when used outdoors, the wood in the hammock stands can deteriorate over time and break. Because the deterioration was occurring inside the metal bracket and was hidden from view, there was sometimes no outward indication to consumers that the wood was rotting until a consumer sat in the hammock and the beams broke. This posed fall and laceration hazards to consumers.
Williams-Sonoma did not file its full report with CPSC until September 11, 2008. On October 1, 2008, Williams-Sonoma and CPSC announced the recall of 30,000 wooden hammock stands. By that time, Williams-Sonoma was aware of 45 incidents involving the hammocks, including 12 reports of injuries requiring medical attention for lacerations, neck and back pain, bruising, and one incident involving fractured ribs.
Federal law requires manufacturers, distributors, and retailers to report to CPSC immediately (within 24 hours) after obtaining information reasonably supporting the conclusion that a product contains a defect which could create a substantial product hazard, creates an unreasonable risk of serious injury or death, or fails to comply with any consumer product safety rule or any other rule, regulation, standard, or ban enforced by CPSC.
November 7th, 2012
in Pharmaceuticals / Biotech / Life Sciences |
The FDA will be affected, in one way or another, by the results of the upcoming election. The FDA would largely continue with its current path if President Barack Obama gets re-elected, according to this blog post. On the other hand, the agency is likely to have a commissioner who is willing to move away from a focus on safety and take steps to speed approvals, notwithstanding budget cuts, if Republican challenger Mitt Romney wins, the blog post said.
Article from Pharmalot.com, by Ed Silverman, posted on 11/05/12:
What Will The FDA Look Like After The Election?
Four more years or a few more weeks? Those are the choices in the upcoming election, but how might this affect the FDA? Apart from an occasional reference, the agency is not part of the campaign dialogue, notes Steve Grossman of the Alliance For A Stronger FDA non profit. And in his view, this is a good thing, since “any intelligent discussion requires a long-term perspective and a mastery of detail and nuance, both of which are in short supply during sound bite-oriented politicking. But of course, the FDA will be affected, one way or the other.
“First, is the potential for 8.2 percent federal budget cuts in January. Sequester, as the process is known, will leave FDA with about $320 million less to spend in Fiscal Year 13 than it did in Fiscal Year 12. This includes cuts to taxpayer-funded FDA appropriations, about a $2.5 billion base, and user fee revenue, nearly a $1.4 billion base). If cuts were applied entirely to FDA personnel, the agency would have to cut or furlough about 1,000 people,” he writes on his FDA Matters blog.
“We know that the sequester of FDA funding has consequences: food will be less safe; drug and device approvals will be slower; problems with imports and globalization will become more numerous; and FDA modernization will be severely slowed. Note that this is the opposite of what everyone – critics included – wants. The precise impact is hard to quantify because FDA will try to prioritize its remaining manpower to avoid immediate disasters and avoid any visible failure to approve life-saving therapies,” he continues.
“Congress does not want to reduce the federal deficit through a sequester. This view is supported by President Obama and his opponent, Governor Romney. Despite this seeming unanimity, an alternative deficit reduction package would need to deal with entitlement programs and taxes. So, politically, deficit reduction is a mess and sequester may happen,” writes Grossman, who is executive director of the non profit, which includes patient advocacy groups, drugmakers, former government officials, law firms, trade groups and consultants (see here).
And what about the commish? Will Margaret Hamburg remain if Obama is re-elected? Will Romney do what former president George W. Bush did and let the agency drift with temporary leadership for months on end? “Historically,” Grossman offers, “change at FDA is affected by the interest level of the President (most Presidents aren’t interested in FDA); a growing or shrinking agency budget; an acting versus a confirmed commish,” and Congress.
Not surprisingly, he offers several scenarios. If Obama remains in the White House, Hamburg is likely to remain as well, at least for the first year, especially if there is no sequester. You can read more about the varying possibilities here, although Grossman notes that “it is only a slight exaggeration to suggest the agency would be set adrift and some panic might set in” if there is a sequester and a long-term acting commish.
“If Governor Romney is elected, then the main drivers of change are likely to be his interest level, how quickly he nominates a new commissioner, how controversial his nominee is, and the federal budget situation,” he writes, adding that his attention is likely to be drawn in many other directions. “The best situation would be a well-known, well-respected, candidate who could win easy confirmation. That person would have the opportunity to make a lot of changes, although there would be notable differences if a new commissioner faces budget cuts.”
What do we think? Of course, ‘well respected’ means different things to different people. The notion, meanwhile, that the FDA would largely continue on its current path with an Obama re-election is not hard to imagine, at least for the short run. With Romney in the White House, however, the agency is likely to look and feel quite differently – and have a commish who is willing to ‘swing the pendulum’ away from an emphasis on safety and take any number of steps to speed approvals, regardless of budget cuts. In fact, a Romney commish is likely to boast about a goal of approving more drugs with fewer resources.
When: Tuesday, November 13 to Wednesday, November 14, 2012
Where: New York Marriott Downtown, New York, NY, USA
Bio and PhRMA have joined forces, urging CMS to delay the Part B Drug Price Substitution Policy until AMP regulations are finalized (which is expected in 2013). Currently, CMS has the authority to use the WAMP calculation (103% of AMP) to alter the reimbursement rate for drugs administered in the physician office under Medicare Part B, though they have not yet exercised this authority.
Because the agency has not yet finalized new regulations regarding the method for calculating AMP following a legislative redefinition in the Affordable Care Act, BIO urged the delay in implementing the substitution and stated in its comments to CMS, , “The final regulations almost certainly will affect the relationship between AMP and ASP, and, accordingly, the appropriateness of price substitution.”
Government drug pricing, particularly in light of the recent changes resulting from health care reform can be confusing for even seasoned pricing professionals, therefore, if you don’t deal with government pricing directly, it can sometimes seem impossible to understand. ACI’s 10th National Rx Drug Pricing Boot Camp has been designed to make sense of the confusion. Whether you are in commercial pricing, legal, finance or technical support, our Boot Camp can teach you the fundamentals you need to know to perform your drug pricing related responsibilities.
This event has been designed to make government drug pricing easy to understand even for those executives not deal directly with drug pricing. Attend the pre-conference workshop to seamlessly join discussions of FDA regulatory law at the main conference. “Government Payor Pricing 101: Primer for Professionals New to Pharmaceutical Pricing” will provide attendees with a basic overview of government payor programs such as Medicare and Medicaid while the main conference will serve as an intensive training in the fundamentals of government pricing concepts and methodologies.
Get the focused and in-depth information you need at the Post-Conference Workshop to maximize your learning and networking experience at this event!
Federal; Government Contracts and Pricing: FSS, VA, DoD, and More will build on the pricing fundamentals covered during the main conference and delve into the core pricing competencies for the “Big Four” government agencies.
Over the years, ACI’s Rx Drug Pricing Boot Camp has become a key industry event for pharmaceutical manufacturers who want to bring their government pricing and related departments up to speed on the latest developments in government payor programs. Manufacturers are already signing up their teams for this year’s event – join your colleagues in ensuring that your pricing executives are ready to face health care reform implementation challenges head-on.
Take advantage of the lowest tuition price by registering early and ensure your spot at what is sure to be a sold out event. Register by October 12, 2012 to lock in the discounted $2095 rate
When: Wednesday, October 24 to Thursday, October 25, 2012
Where: Sutton Place Hotel, Chicago, IL, USA
You cannot afford to be left in the dark regarding FDA medical device regulations
Whether you are an a products liability litigator, patent counsel, business or investment expert, medical or regulatory affairs professional, or industry in-house counsel, FDA Boot Camp – Devices Edition will arm you with the tools you need to have a strong working knowledge of core FDA regulatory competencies. Now in its second year and part of ACI’s successful FDA Boot Camp franchise, the Devices Edition will take a special focus on the law and regulation of medical devices and provide you with the regulatory grounding necessary to enhance your practice.
Save the phone calls to your colleagues or other regulatory counsel for the truly complicated issues; attend ACI’s FDA Boot Camp – Devices Edition to boost your FDA regulatory IQ. The Boot Campboasts a preeminent faculty of the nation’s leading food and drug lawyers—many of whom previously served as legal counsel at FDA—who will drill you in the basics of FDA devices law and regulation.
- Tailor your experience by attending the pre-conference workshop and post-conference master class
- Stay ahead of the curve with a special focus on developing issues relating to the changes in 510(k) clearance
- Have your questions answered in a high level collaborative environment
- Obtain 2 years experience, updates and networking in just 2 days, while earning CLE credits for the year
- Learn directly from the nation’s leading members of the Food and Drug bar
Five reasons you should attend this event:
Meet and gain insights from renowned FDA devices attorneys including industry in-house counsel, Karen Weaver from CareFusion
The Master Class on Unique Regulatory Schemes for Specialized Devices: In Vitro Diagnostics and Software Classified as Devices will provide critical analysis of major recent regulations of IVDs anddevelopments in the evolving regulatory landscape of LDTs and will delve into the unique regulatory structure governing medical device software
In-depth discussion will be provided on recalls and withdrawals of devices
Get expert insights about working with the FDA and the nature of the approval process
Move through the approval process more quickly by gaining a greater understanding of the regulation of clinical trials, IDEs, 510(k) clearance, and PMAs
When: Monday, October 22 to Wednesday, October 24, 2012
Where: The Union League, Philadelphia, PA, USA
Recently, U.K. watchdog the Medicines and Healthcare products Regulatory Agency, and regulator European Medicines Agency, took a major pharmaceutical manufacturer to task for failing to adequately report adverse events. In order to successfully research, manufacture and sell your product, you need to harmonize U.S. and non-U.S. regulatory obligations. ACI’s Drug Safety, Pharmacovigilance & Risk Management Forum will offer practical strategies for developing a comprehensive drug safety program that can satisfy multiple and varied regulatory obligations.
As a drug manufacturer, your company has a duty to examine every suspected side effect and report them to regulators around the world so that potential safety concerns can be investigated. Dr. Steven Du, Senior Director, Pharmacovigilance & Pharmacoepidemiology, at AMAG Pharmaceuticals will teach you how to:
- Determine the best way to work across organizational and geographical boundaries to manage global risk
- Ensure adequate oversight, monitoring and auditing over third party manufacturers
- Ceate inspection/audit procedures to ensure that REMS commitments are carried out
- Handle a finding of less than 100% compliance
- Mitigate the risks of outsourcing to emerging markets such as China and India
- Integrate pharmacovigilance and marketing authorization approval
- Collaborate with non-EU regulatory agencies to create a surveillance system capable of rapid response
The learning does not end with the conference. Take advantage of added workshop opportunities:
WORKSHOP A | OCTOBER 22, 2012
Fundamentals of FDA Regulatory Law
Aimed at providing a primer to professionals who have limited experience working with FDA on regulatory matters, or who are new to the pharmacovigilance space, this workshop will provide you with a basic overview of FDA regulations and prepare you for the more in-depth conversations that will take place at the conference.
WORKSHOP B | OCTOBER 24, 2012
The “Win-Win” Pharmaceutical Manufacturing Outsourcing Agreement: Practical and Ethical Drafting and Negotiating Strategies for Pharmerging Markets
At a time when manufacturing outsourcing has become the norm for most pharmaceutical companies, it is increasingly necessary to develop negotiating skills that ensure the parties to the contract carry out the true intentions of the deal.
When: Thursday, October 18 to Friday, October 19, 2012
Where: The Carlton Hotel, New York, NY, USA
Prepare to meet the anticipated challenges of ‘OTC drugs with conditions of safe use’ as you master existing legal and regulatory protocols for non-prescription pharmaceutical products.
FDA’s proposed introduction of a new paradigm for ‘OTC drugs with conditions of safe use’ (which some industry observers have referred to as a third class of drug product or ‘behind the counter’/ ‘BTC’ products ) will put a new twist on existing legal and regulatory protocols and product commercialization in the OTC space. Self-diagnosis and self-care, two basic tenants of the current OTC paradigm may be supplemented with the assistance of a pharmacist and rapid diagnosis testing, thus leading to a multitude of questions ranging from scope of FDA authority to potential liabilities.
To help you make sense of this new proposal and its potential impact on existing legal and regulatory structures in the OTC environment, ACI has developed the Legal, Regulatory and Compliance Forum on Over the Counter Drugs. Over two dozen legal and regulatory OTC experts from such leading companies as GlaxoSmithKline Consumer Healthcare; Merck & Co., Inc.; Novartis Consumer Health, Inc.; Perrigo Company; and Pfizer will present at this unique industry event. This distinguished faculty will address existing and anticipated challenges affecting such core OTC functions as:
- Advertising and promotion
- Trademarks, trade names and line extensions
- The modernization of the monograph system
- Rx to OTC switches
- AER protocols
- Recalls and remediation strategies
Additionally, key FDA and USP representatives will present at this event on such critical and industry game changing matters as:
- The Ramifications of FDA’s Proposed New Paradigm for OTC Drugs with Conditions of Safe Use
- Nicholas E. Beshara, Associate Chief Counsel, Office of the Chief Counsel
United States Food & Drug Administration
- Trends in Recent OTC Enforcement Actions and Litigation:Lessons Learned for Risk Mitigation and Compliance
- Eric Blumberg, Litigation Deputy, Office of the Chief Counsel
United States Food & Drug Administration
- Modernizing the Monograph System and the OTC Drug Review Process in Light of New OTC Drivers and Technologies
- Matthew Van Hook, Assistant General Counsel, Compendial Sciences
The United States Pharmacopeial Convention
When: Wednesday, October 10 to Thursday, October 11, 2012
Where: New York Marriott Downtown, New York, NY, USA
Over 3000 patent professionals representing both branded and generic manufacturers have learned why ACI’s Maximizing Pharmaceutical Patent Life Cycles Conference is the original and best drug life cycle management conference in the U.S. This year’s iteration will without a doubt continue the event’s long tradition of excellence in educating top professionals on the details of this complex but vital aspect of effective patent portfolio management. Featuring government officials from the USPTO, FDA, and FTC, our faculty will share best practices for:
- Understanding how the patent cliff will impact innovation and R&D, and alter the industry dynamic between brand names and generics
- Preparing for how the recently issued FDA regulations on biosimilars and the further implementation of BPCIA will affect pharmaceutical patent life cycle management strategies
- Assessing how the combined evolution of prior art obvious and obvious-type double patenting are influencing the future of secondary patents
- Evaluating patent life cycle strategies relative to personalized medicine vis-à-vis section 101 patentability post-Prometheus
- Examining the impact of REMS studies on generic entry
- Deciphering the relationship between use code controversies and inducement and divided infringement actions relative to Orange Book listings post-Caraco
- Exploring forfeiture rulings post-Lipitor
- Navigating new safe harbor dilemmas for both general screening and research tool patents
ADDED LEARNING VALUE
We are also pleased to offer the in-depth and practical training and strategy sessions that will address the essential and emerging focus of pharmaceutical patent life cycle management:
- Working Group Session: Assessing the Impact of New PTO Procedures Under the AIA on Hatch-Waxman Strategies Relative to Patent Life Cycle Management will offer in-depth and pragmatic advice for navigating the PTO’s new post-grant review and inter partes review proceedings, and much more.
- PTA- PTE Boot Camp: Basic Training in the Essentials of Patent Term Adjustment and Patent Term Restoration for Patent Lawyers Serving the Biopharmaceutical Industry will offer critical instruction on the fundamentals and mechanics of PTA and PTE practice which help to ensure patent and profit longevity
With a track record of attracting top counsel and business development executives from both branded and generic drug manufacturers, this event is a prime networking opportunity. Past iterations of have sold out – visit the conference home page, learn more about our exciting faculty of in-house, private practice, and government experts, and reserve your spot today!
When: Wednesday, October 03 to Thursday, October 04, 2012
Where: Millennium Knickerbocker, Chicago, IL, USA
Over the past month, the FDA has been busy issuing reports, releasing guidance and taking regulatory action as per directives required under the Food Safety Modernization Act, including:
- The recent issuance of the 2012 Annual Report on Food Facilities, Food Imports, and FDA Foreign Offices
- Publication of an updated guidance for industry on the use of food categories in food facility registrations
- A pending proposal to amend the food additive regulations to no longer provide for the use of Bisphenol A
How is your company prepared to respond to the many new regulatory changes expected under FSMA?
An invaluable opportunity to network and benchmark with your in-house peers, while also gaining firsthand insights directly from the FDA, FSIS, USDA and FTC, ACI’s FDA & USDA Compliance Boot Camp will include several sessions specifically dedicated to addressing new food safety requirements under FSMA, including:
- IMPORTS – how to ensure the safety of your food supply and comply with expected reform under Title III
- INSPECTIONS – addressing new Government jurisdiction and authority – what your company can do now to prepare
- FOOD and ANIMAL FEED – inside the current debate surrounding the agricultural use of antibiotics in livestock
Also benefit in-depth sessions on:
- The Jurisdiction, Function, Organization and Operations of the FDA, USDA, FTC and Other Health Agencies
- The Core Components of a Compliant Package Label
- GRAS and the Premarket Review and Approval Process for Food Additives
- How to Meet Strict FDA and USDA Food Safety Regulations to Prevent Adulteration and Contamination
- What Can and Cannot Be Said When Crafting Marketing and Advertising Claims
- How to Prepare and What to do to Prevent Pitfalls during Government Inspections
Take part in the following Mock Scenarios:
- How to Bring a New Food Market to Product – Best Practices of Ensuring Your Product Complies with Regulatory Requirements Across all Fronts
- Recall Management – How to Effectively Oversee a Recall and Avoid Common Mistakes that Lead to Litigation
Learn how to connect the dots of food regulatory law while gaining a clearer
understanding of how the FDA, USDA and FTC work together to regulate the food industry.
Optimize your networking opportunities by joining us at the Interactive Working Group:
A – FDA, USDA and FTC Food Law Fundamentals
B – Food Counsel’s Guide to Navigating the Legal Landscape in California
An added benefit of attending this event, attendees will receive a printed binder of materials which will include references to and copies of all the key regulations governing food and beverage products as well as all speaker presentation materials. Attendees are free to keep this binder and refer to it as a reference guide that can be shared and utilized as an information resource once back in the office.
When: Thursday, September 20 to Friday, September 21, 2012
Where: Omni Parker House, Boston, MA, USA
Over the past 8 years, thousands of your fellow legal professionals – from Associates to Partners to GCs have relied on ACI’s FDA Boot Camp Conference to provide them with both a comprehensive overview of the basics of FDA law and current information on the status of regulatory law in the pharmaceutical, biotechnology, and medical device industries.
We hope that this time you will be able to join your peers as this unique event returns to Boston in September.
Learn FDA regulatory basics from the experts—a veritable Who’s Who of the FDA Regulatory Bar—and save the calls to regulatory counsel for the really complicated questions. Come, hear, and learn from a stellar faculty of the nation’s leading food and drug lawyers, who will explain:
- The application and approval processes for drugs, biologics, and devices
- The regulatory balance between brand name and generic products
- The complexities of the patent and IP landscape, including Hatch-Waxman, Orange Book, 180-day exclusivity, 30-month stay, Paragraph IV, NDA, ANDA and 505(b)(2)
- The pivotal role of labeling in the drug and biologics approval process
- The importance of cGMPs to the post-approval regulatory process
- Advertising and Promotion, DTC Advertising, & Off-Label
- The protocols of adverse events monitoring, pharmacovigilance, and REMS
- Non-patent exclusivity, bioequivalency, and Follow-On Biologics
- Recalls, product withdrawals, and FDA oversight authority
Investing just two days at this event will allow you to round out
your FDA regulatory knowledge and enhance your practice
Save the phone calls to your colleagues or other regulatory counsel for the truly complicated issues; attend ACI’s FDA Boot Camp to boost your regulatory IQ.