CMS and FDA Announce New Parallel Review Process for Medical Products

(Robert F. Church et al., Hogan Lovells)

On September 17, 2010, the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) issued a notice describing a new, voluntary parallel review process under consideration by these agencies for medical products.1 Although still in the early stages of its development, it represents a potential opportunity for new technologies, particularly those that would face coverage challenges after FDA approval, to pursue affirmative coverage on a more expedited timetable than currently available. The agencies have provided some details about the parallel review process, and seek comments on a number of aspects of the contemplated parallel review process, which must be submitted by December 16, 2010. The agencies also discuss a small pilot program for the parallel review process. Read more here.

Food Safety Legislation Won’t Mend Regulatory Divide

(Chicago Tribune – P.J. Huffstutter and Andrew Zajac)

Next week’s Senate hearing on the Iowa egg recalls could shed new light on the confusing separation of powers between the FDA and the USDA. As lawmakers prepare for hearings into the largest egg recall in U.S. history, food safety advocates say the congressional probe could give momentum to a long-delayed measure that would enhance the power of the Food and Drug Administration.

If passed, say policymakers, the FDA Food Safety Modernization Act could be the first major step toward streamlining the often unwieldy food safety system.

Lawmakers will grapple with the circumstances surrounding the recall this week in a congressional probe of the outbreak of salmonella enteritidis that has sickened more than 1,500 people. Read more here.

Senator Says He Will Hold Up Food Safety Bill

(FoodNavigator.com – Caroline Scott-Thomas)

Senator Tom Coburn (R-OK) has said he intends to hold up food safety legislation that has been stalled in the Senate since last November, as there is no indication of how it would be funded. “Without paying for this bill, at best we are just passing it for a press release, and at worse, we shackle the FDA with unfunded mandates,” Coburn said in a document published on his website on Wednesday.

Supporters of the Food Safety Modernization Act have been pushing to get the bill on the Senate’s agenda as soon as possible, particularly in the wake of the nationwide egg recall that has sickened at least 1,500 people. They claim that the bill is necessary to strengthen the Food and Drug Administration (FDA), giving it authority to order recalls, and requiring better recordkeeping from food manufacturing facilities. Read more here.

Medical Devices Reimbursement Workshops – Winnipeg & Edmonton, Sept 20-23

(FAITC)

Date: September 20-23, 2010
Location: Winnipeg and Edmonton, Canada

Contact: Cynthia Stevenson, Trade Commissioner (Health Industries), Canadian Embassy, Washington, D.C. cynthia.stevenson@international.gc.ca

One-day workshops in Winnipeg and Edmonton for medical device companies on developing a market strategy that integrates reimbursement, the FDA regulatory process, securing investment/VC partners, and successful commercialization through appropriate business partners and distribution channels.

FDA Pre-Market Approval Workshops – Toronto & Montreal, Sept.21-23

(FAITC)

Date: September 21 to 23, 2010
Location: Toronto and Montreal, Canada

Contact: Cynthia Stevenson, Trade Commissioner (Health Industries), Canadian Embassy, Washington, D.C. cynthia.stevenson@international.gc.ca

Two specialists from the FDA’s Center for Devices and Radiological Health will present day-long workshops to Canadian manufacturers of medical devices and technologies and supporting institutional stakeholders that are approaching completion of product development with intent to export to the U.S. in the near term. The workshops address in-depth the requirements for Pre-Market Notification (510(k)) and Pre-Market Approval (PMA) procedures for the importation of medical devices and technologies into the U.S.

Egg Recall Renews Calls for Movement on Food Safety Legislation

(FoodNavigator.com – Caroline Scott-Thomas)

A massive multi-state recall of salmonella-tainted shell eggs has led to renewed calls for food safety legislation to move forward in the Senate, as the number of related illnesses looks likely to grow, according to officials.

The recall covers an estimated 380 million in-shell eggs – and products made from them – from Iowa-based Wright County Egg. The recall affects food retailers, distributors and foodservice companies that distribute eggs nationwide, but does not directly affect commercial food manufacturers, as eggs must be pasteurized for commercial food use.

Food safety director at the Center for Science in the Public Interest Caroline Smith DeWaal said in a statement: “This outbreak demonstrates the need for a food safety cop-on-the-beat. FDA needs a strong inspection force with the tools to mandate recalls, impose civil and criminal penalties, and require testing at farms and production facilities. The agency should be able to impose fines for violations when they find them, detain and recall food, and impose enhanced criminal penalties when companies intentionally violate the law, resulting in harm to the public. The Senate should move immediately to pass S. 510 and Congress should move a bill that incorporates the strongest enforcement provision of each bill promptly to the President’s desk for signature.”

The Food Safety Modernization Act (S.510) is currently pending consideration in the Senate after it unanimously passed committee in November. A companion bill, the Food Safety Enhancement Act, passed through the House in July last year. Read more here.

FDA Inspection of Foreign Food Facilities

(Mondaq – Andrew Hudson, Hunt & Hunt)

The U.S. Food and Drug Administration (“FDA”) has issued notices to all foreign food facilities registered with the FDA advising that it plans to conduct an inspection of those facilities between 1 October 2010 and 30 September 2011.

The FDA inspection scheme affects facilities that manufacture, process, pack, hold or ship food to the United States.

The FDA has issued notices only to foreign food facilities that are registered with the FDA. Under the Bioterrorism Preparedness and Response Act (2002), any foreign food facility that manufactures, processes, packs, holds or ships food to the United States is required to be registered with the FDA. If your facility engages in any of these activities and you are not yet registered, you are advised to visit http://www.fda.gov to register or contact us for further advice or assistance.

The FDA has reported that the inspections are designed to:

“identify potential food safety problems before products arrive in the United States, to determine compliance status of firms to FDA’s requirements, and food safety standards, to help the agency make admissibility decisions when food products are offered for importation into the United States, and to help ensure that food products under FDA’s jurisdiction meet U.S. requirements under the Federal Food, Drug, and Cosmetic Act.”

Foreign food facilities that do not comply with an inspection notice risk having their products refused for admission into the United States and may have their registrations terminated.

FDA Product Code Changes for Tobacco Products

(CBP)

Due to legislative changes in the regulation of Tobacco products, FDA will be ending the following 3 product codes 30 days from the date of this message, which is being issued on August 17, 2010.

80M--SN Cigarettes (containing Tobacco)
80M--SO Tobacco, Cigarette (for use in making)
80M--SP Tobacco, Smokeless (cut, ground, powdered, or leaf intended to be placed in oral cavity)

They have been replaced by the following more specific product codes which are already active.

CFIA: Reminder of Changes to Import Notification Requirements – Second Phase

(CFIA)

This is a reminder to all importers and brokers that the second phase of implementation of new import notification requirements for selected commodities regulated solely under the Food and Drugs Act and Regulations will come into effect on July 19, 2010.

Please click here to direct you to the Reminder Notice on the CFIA website. The Reminder Notice provides a listing of the products and the corresponding HS codes that will be affected by this new notification requirements.

U.S. Unveils Broad Crackdown on Piracy, Counterfeit Goods

(Jennifer Martinez — LA Times)

The government-wide effort includes adding 50 FBI agents to focus on intellectual property infringement

The Obama administration unveiled a government-wide strategy Tuesday to crack down on piracy and counterfeit goods, adding more than 50 FBI agents this year to tackle intellectual property abuses.

With the ubiquity of the Internet, online piracy and the sale of counterfeit goods on the Web are growing rapidly across a range of industries, including entertainment, software and pharmaceutical markets.

Vice President Joe Biden, who announced the new program, said that the problem costs Americans jobs and that counterfeit goods threaten lives.

“Whether we’re talking about fake drugs that hurt ... or knock-off car tires that fall apart at 65 miles per hour causing injury and death, counterfeits kill,” Biden said at a White House meeting that included Atty. Gen. Eric H. Holder Jr., Homeland Security Secretary Janet Napolitano and Food and Drug Administration Commissioner Margaret Hamburg. Read more here.

FDA Information Collection on Safe Import Procedures for Fish Products

(World Trade Interactive)

The Food and Drug Administration is requesting public comments by July 19 on the proposed extension of an information collection concerning procedures for the safe and sanitary processing and importing of fish and fishery products.

FDA regulations mandate the application of hazard analysis and critical control point principles to the processing of seafood and require that processors and importers of seafood collect and record information. The HACCP records compiled and maintained by a seafood processor primarily consist of the periodic observations recorded at selected monitoring points during processing and packaging operations. HACCP records are normally reviewed by appropriately trained employees at the end of a production lot or at the end of a day or week of production to verify that control limits have been maintained or that appropriate corrective actions were taken if the critical limits were not maintained.

A review of these records during the conduct of periodic plant inspections permits FDA to determine whether the products have been consistently processed in conformance with appropriate HACCP food safety controls. Article and link to source document here.

Precaution Should Be Watchword of FDA, Says IOM

(FoodNavigator.com – Jane Byrne)

The Food and Drug Administration is not currently equipped to handle food safety problems and needs to switch to a risk based system, argues a report from the Institute of Medicine and the National Research Council.

The committee that wrote the report states that the FDA’s abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hindered by limited resources and a piecemeal approach to gathering and using information on risks.

Calls to overhaul America’s food safety system intensified last year on the back of a spate of multi-state foodborne illness outbreaks. Support from food manufacturers also strengthened after the salmonella outbreak linked to peanut products led to more than 700 illnesses and nine deaths, as well as one of the largest product recalls in U.S. history, at an estimated cost of at least $1bn. Read more here.

Related: FDA Chief: Agency Is Committed to Improving on Food Safety Issues (PBS Newshour)

Unsafe By Definition? GM/GE-Free Product Labeling

(Consumer Reports)

What it is: GM/GE refers to genetically modified or genetically engineered products. GM/GE processes may be useful because they can transfer certain traits and properties from one organism to another. For example, soybeans can be given a gene that protects them from the herbicide that’s sprayed on the field to kill weeds.

Why it’s news: There are currently no mandatory government labeling requirements for GM/GE products. Growers and product makers are allowed to label their goods as GM-free or GE-free. At an international meeting on food labeling in Quebec City, Canada in early May, the U.S. Department of Agriculture and the U.S. Food and Drug Administration came out against a proposal to allow countries to adopt different approaches to labeling of GE/GM foods, as long as they are in line with existing U.N. guidelines. Read more here.

U.S.-Based Food Safety Training for Foreign Food Manufacturers

(FoodNavigator.com – Caroline Scott-Thomas)

The University of Maryland and Waters Corporation have partnered to open a facility in Maryland to train foreign food manufacturers and scientists in methods of analysis to help them meet US food safety standards.

The International Food Safety Training Laboratory (IFSTL) will be run by the Joint Institute for Food Safety and Applied Nutrition (JIFSAN), a new collaboration between the University of Maryland and the US Food and Drug Administration (FDA). The IFSTL is expected to open next year.

Imports account for about 15% of the total US food supply, including 60% of fresh fruit and vegetables and 80% of seafood. According to the Government Accountability Office, there are about 189,000 registered foreign sites where food is made for sale in the United States, but the FDA only inspects a tiny fraction of them – just 153 in 2008. Read more here.

FDA Transparency Plan Addresses Food Safety Inspections, Recalls

(CIDRAP – Lisa Schnirring)

As part of a push for more government transparency, the U.S. Food and Drug Administration (FDA)… released a draft report detailing 21 steps it could take to share more information, such as providing fuller explanations of its decisions and posting more inspection reports.

Most of the proposals in the 65-page report apply to drugs and devices that the FDA regulates, but some measures address food safety issues such as import evaluations, facility inspections, and product recalls.

The proposals reflect President Barack Obama's goal of creating more openness in government and are part of a transparency initiative launched by Dr Margaret Hamburg when she stepped into her new role as FDA commissioner in June 2009.

New FDA Product Codes in Industry 98 – Tobacco Products

(CBP)

FDA has added 9 new product codes at the request of their Center for Tobacco Products (CTP). If you are transmitting entry information for the product(s) described below, please begin using these new codes immediately.

Class B – Cigarettes
98B- -06 Cigarettes, Light, Mild, or Low, Unflavored
98B- -07 Cigarettes, Light, Mild, or Low, Flavored (Menthol)
98B- -08 Cigarettes, Light, Mild, or Low

Class C - Smokeless Tobacco
98C- -08 Chewing Tobacco, Light, Mild, or Low, Loose Leaf
98C- -09 Chewing Tobacco, Light, Mild, or Low, Plug
98C- -10 Chewing Tobacco, Light, Mild, or Low, Twist
98C- -11 Snuff, Light, Mild, or Low, Dry
98C- -12 Snuff, Light, Mild, or Low, Moist
98C- -13 Snus, Light, Mild, or Low

Please begin using these new codes immediately where appropriate to identify the product being submitted for entry, using currently existing conventions for building a product code for CTP regulated products.

FDA Seeks Industry Comments on Food Safety During Transport

(FoodNavigator-USA.com – Caroline Scott-Thomas)

The Food and Drug Administration (FDA) has released an advance notice of proposed rulemaking (ANPRM) on establishing guidance intended to reduce the risk of food contamination during transportation. The agency has asked the food industry to comment on rule proposals to govern the transportation of foods in the United States, as well as calling for comments from the transportation sector and consumer interest organizations. […]

FDA’s associate commissioner for food protection, Jeff Farrar said: “Our aim is to look at every component of the system to assess hazards, and to take science-based action where appropriate to maximize the safety of our food from farms all the way to consumers’ tables. Although contamination of food product during commercial transport is relatively infrequent, the potential harm can be widespread and serious.”

Read more here. The advance notice of proposed rulemaking – and instructions on how to comment – is available online here. The comment period is due to close on August 30, 2010.

Dairy Industry Lobbies to Cut Milk from Soy Milk

(FoodNavigator-USA.com – Guy Montague-Jones)

A dairy industry group is lobbying the Food and Drug Administration (FDA) to banish the term ‘soy milk’ and stamp out any other use of dairy-specific terms to describe non-dairy products. The National Milk Producers Federation (NMPF) has sent a petition to the FDA urging the regulator to crack down on what it calls “the misappropriation of dairy terminology on imitation milk products.”

Since the NMPF first complained to the FDA about the practice a decade ago, the trade body argues that it is now more common than ever. In addition to the proliferation of terms like ‘soy milk’ and ‘soymilk’, the petition to the FDA contends that other dairy product names like cheese, yogurt and ice cream are being used by makers of non-dairy products.

The NMPF describes this as “false and misleading” labeling. Jerry Kozak, NMPF president and CEO, accuses the FDA of letting the issue slide so that the meaning of ‘milk’ has now been “watered down to the point where many products that use the term have never seen the inside of a barn.” Read more here.

FDA Urges Medical Industry to Prevent Cargo Thefts

(UPI)

The U.S. Food and Drug Administration sent a letter to medical firms Wednesday, expressing concern about cargo and warehouse thefts of FDA-regulated products. FDA Acting Assistant Commissioner for Regulatory Affairs Michael Chappell said the stolen products have included prescription and over-the counter medicines, medical devices, vaccines and infant formula.

In the letter Chappell asked the industry to review and strengthen security practices. “There have been several cases where patients experienced adverse reactions from stolen drugs, reactions that were most likely due to improper storage and handling,” Chappell wrote. “We do not want to see this increase in thefts continue.” Read more here.

CBP, CPSC Sign Agreement to Promote Consumer Safety

(CBP)

U.S. Customs and Border Protection Commissioner Alan Bersin and U.S. Consumer Product Safety Commission Chairman Inez Tenenbaum today [April 26] signed a memorandum of understanding for CBP’s Import Safety Commercial Targeting and Analysis Center. The MOU will allow CPSC personnel to access CBP commercial automated systems for import safety risk assessments.

“This is an important first step in strengthening our ability to promote consumer well-being and safety,” said Commissioner Bersin. “With this memorandum of understanding, CBP and the Consumer Products Safety Commission will be able to further protect consumers against the importation of dangerous goods into the U.S.”

The MOU gives CPSC the capability to conduct import safety risk assessments and perform targeting work using CBP’s Automated Commercial System.

“This cooperation between federal partners is making U.S. consumers more safe. By identifying and checking consumer products at our ports, we can reduce the flow of dangerous products into our homes,” said CPSC Chairman Inez Tenenbaum.

The Import Safety CTAC reflects the three core principles announced by President Obama’s Food Safety Working Group in July 2009: prevention, surveillance and response. Created in March 2009, the Working Group was tasked with advising President Obama on how to upgrade the U.S. food safety system for the 21st Century.

CBP established the CTAC Oct. 1, 2009, as a fusion center for agencies to share targeting resources, analysis, and expertise to achieve the common mission of protecting U.S. citizens from unsafe imports. In addition to CBP, the government agencies represented at CTAC include the Consumer Product Safety Commission, the Food and Drug Administration, and the U.S. Department of Agriculture’s Food Safety Inspection Service.

Related: Lawmakers Consider Bill to Address Problems with Product Safety Law (World Trade Interactive)