Friday, April 1, 2011

FDA Proposes Draft Menu and Vending Machine Labeling Requirements

The FDA releases documents today regarding proposed regulations for restaurants and vending machine operators to include nutrition details on their menus and vending machines, as part of a healthcare law passed last year.

The FDA proposed that certain restaurants and retail food establishments provide nutrition information for standard menu items, including food on display and self-service dishes.

The rules target restaurants with 20 or more locations, as well as other retail food outlets, coffee shops and convenience stores.  However, a notable exemption to the proposed rules are movie theaters.

The FDA also proposed that companies owning and operating 20 or more food vending machines would be required to provide calorie information in close proximity to the food item or selection button. 

The FDA is seeking public comment on the proposed rule for menu labeling for 60 days (until 06-06-2011). Comments on the proposed rule on vending machines may be submitted for 90 days (until 07-05-2011). The FDA plans to issue final rules before the end of 2011.

The documents may be downloaded here:
1. Food Labeling; Nutritional Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments (pdf); docket number FDA-2011-F-0172

2. Food Labeling; Calorie Labeling of Articles of Food in Vending Machines (pdf); docket number FDA-2011-F-0171

Friday, March 11, 2011

FDA Clarifies Malfunction Reporting Requirements For Class I and Low-Risk Class II Devices

The FDA has issued a clarification regarding medical device manufacturers’ and importers’ compliance with malfunction report rules according to the agency’s Medical Device Reporting regulation.

The requirements temporarily cover not only high-risk devices but also Class I and II devices that are not permanently implantable, life-supporting or life-sustaining.

The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires manufacturers and importers of Class III as well as permanently implantable or life-supporting Class II devices to submit malfunction reports unless granted exemptions by the US Secretary of Health and Human Services or FDA. The FDAAA changed such rules for Class I and low-risk Class II devices, requiring quarterly reporting of malfunctions in summary form, except in instances where the regulator deems a device subject to stricter reporting rules in order to protect public health. In such instances, the FDA will notify those device manufacturers or importers in writing—or post a Federal Register notice—that they would have to provide malfunction reports in a manner that fully complies with the FDA’s Medical Device Reporting rule.

For the time being, however, the FDA will now require all devices to malfunction reporting requirements previously targeting higher-risk devices. The agency plans to more clearly define which devices fall under the less rigorous quarterly malfunction reporting category. In the meantime, the FDA’s clarification states that the agency will subject all devices to more exacting reporting requirements “in order to protect the public health by ensuring that there is no gap in malfunction reporting for any device.”

Interested parties may submit written or electronic comments on the clarification until May 9.

Tuesday, February 22, 2011

Design-defect Claims Against Vaccine Makers Preempted, Supreme Court Rules

The Supreme Court on Tuesday shielded the nation's vaccine makers from being sued by parents who say their children suffered severe side effects from the drugs.

By a 6-2 vote, the court upheld a federal law that offers compensation to these victims through a special tribunal but closes the courthouse door to lawsuits.

The majority said that Congress found such a system necessary to ensure that vaccines remain readily available, and that federal regulators are in the best position to decide whether vaccines are safe and properly designed.

The National Childhood Vaccine Injury Act of 1986 "reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries," Justice Antonin Scalia wrote, referring to the Food and Drug Administration.

Justices Sonia Sotomayor and Ruth Bader Ginsburg dissented, saying the threat of lawsuits provides an incentive for vaccine manufacturers to constantly monitor and improve their products.

The decision "leaves a regulatory vacuum in which no one - neither the FDA nor any other federal agency, nor state and federal juries - ensures that vaccine manufacturers adequately take account of scientific and technological advancements," Sotomayor wrote.

The case was brought by Russell and Robalee Bruesewitz on behalf of their daughter Hannah, 18. Hannah began to have seizures as an infant after receiving the third of five scheduled doses of Wyeth's Tri-Immunol diphtheria-pertussis-tetanus vaccine. The company, now owned by Pfizer, has taken the drug off the market.

The 1986 federal law said that all such claims must first go to a special tribunal commonly called the "Vaccine Court." The program has awarded nearly $2 billion for vaccine-injury claims in nearly 2,500 cases since 1989. It is funded by a tax on immunizations.

But the tribunal ruled against the Bruesewitzes, saying they had not proved that the vaccine harmed Hannah, who will need life-long care.

The couple then sued under Pennsylvania tort law. The company had the case moved to federal court, and judges have consistently ruled that the suit cannot proceed, because federal law prohibits claims against "design defects" in vaccines.

The justices at oral argument debated ambiguous wording in the federal law. It says that no vaccine maker can be held liable for death or injuries arising from "side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings."

Scalia said the word "unavoidable" would be meaningless "if a manufacturer could be held liable for failure to use a different design."

Sotomayor read the language to mean the opposite, and said "text, structure and legislative history compel the conclusion that Congress intended to leave the courthouse doors open for children who have suffered severe injuries from defectively designed vaccines."

The case is Bruesewitz v. Wyeth.

Wednesday, February 16, 2011

FDA to reclassify Medical Device Data Systems

The FDA has published a final rule to reclassify Medical Device Data Systems (MDDS) from Class III devices requiring premarket approval to Class I devices regulated under much less stringent general controls.

“An MDDS is a device that is intended to transfer, store, convert from one format to another according to preset specification, or display medical device data,” according to the rule. “An MDDS acts only as the mechanism by which medical device data can be transferred, stored, converted or displayed. An MDDS does not modify the data or modify the display of the data. An MDDS by itself does not control the functions or parameters of any other medical device. An MDDS can only control its own functionality. This device is not intended to provide or be used in connection with active patient monitoring. Any product that is intended for a use beyond the use (or functions) identified in this final classification rule is not an MDDS and is not addressed by this rule.”

The final MDDS rule will apply to “all manufacturers,” the FDA says. Critically, this includes hospitals, health care facilities or any other organization that does any of the following:
  • Makes any modifications to the MDDS that are outside the parameters of the original manufacturer’s specifications for the device, for purposes of the user’s clinical practice or otherwise for commercial distribution.
  • Purchases hardware or software and modifies it to transfer, store, convert or display medical device data for clinical use.
  • Develops in-house software with an intended use consistent with an MDDS.
  • Develops an in-house system, using multiple components of devices, that has an intended use consistent with an MDDS.
Other key points from the preview to the MDDS final rule include the following:
  • The rule does not apply to electronic health record (EHR), personal health record (PHR), computerized physician order entry (CPOE), e-prescribing or word processing systems. Laboratory information systems and picture archiving and communication systems (PACS) are not medical device data systems either.
  • An MDDS can covert data to the HTML; PDF; or Health Level Seven International, or HL7, data formats. However, “an MDDS may not otherwise convert, alter, modify or interpret the data that is received from a medical device,” the FDA said.
  • Devices that transfer information for the purpose of information exchange, or that can generate or manipulate data on their own, are not considered medical device data systems.
  • Such devices as glucose monitors, blood pressure cuffs and active patient monitors are not MDDS. These are Class III devices because they directly support and sustain a patient’s life; as such, they remain subject to stricter regulatory control, as well as to premarket approval.
  • Devices intended for use by people who are not health care professionals (data entry clerks, for example) count as MDDS, though the FDA reserves the right, “if, through normal reporting mechanisms or otherwise, FDA determines that the use of these devices by someone other than a health care professional poses an unreasonable risk of illness or injury.”

Wednesday, January 19, 2011

FDA to Revise Device Rules, but Most are Minor for Now

In a press release today, the FDA announced that it will be making 25 changes this year to its 510(k) medical device clearance program, but will hold off on any major moves until after the release of an Institute of Medicine (IOM) report scheduled for this summer.

The agency's Center for Devices and Radiological Health said it would implement changes including the streamlining of the "de novo" review process for lower-risk devices, more clarity on when medical device manufacturers must submit clinical data in a 510(k) submission, and the creation of a council to improve regulatory science.

Most of the controversial changes to the 510(k) program proposed by the agency last year were temporarily taken off the table until the release of the IOM review slated for this summer.  They include the ability to revoke 510(K) clearances, increased post-market surveillance, and the establishment of a new classification (IIb) for medical devices that would require the submission of clinical evidence.

The agency maintains that the changes (PDF) will be a boon for the process by which the vast majority of medical devices are cleared for the U.S. market, delivering "a smarter medical device program that supports innovation, keeps jobs here at home and brings important, safe and effective technologies to patients quickly," according to a statement by Shuren.

In order to facilitate innovation in medical devices, Shuren said the FDA will:
  • Streamline the review process for innovative, lower-risk products, called the "de novo" process by Sept. 30.
  • Publish guidance for industry to clarify when clinical data should be submitted to increase predictability and transparency on July 31.
  • Develop a network of external experts who can use their knowledge and experience to help the agency address important scientific issues regarding new medical device technologies by Sept. 15.
  • Establish a new Center Science Council of senior FDA experts within the agency’s medical device center to assure more timely and consistent science-based decision making. FDA will publish the charter for the council its website on March 31. The agency plans to publish initial results of a 510(k) audit by the council on June 15.
To bolster the safety of medical devices, Shuren said the FDA will:
  • Establish a public database of important device information, such as medical device photographs, labeling and summaries of the basis for the FDA’s decision to clear specific devices. The database will be discussed at a public meeting taking place April 7 and 8.
  • Require a brief description of scientific information regarding the safety and effectiveness known to the manufacturer for select higher-risk devices on a case-by-case basis through device-specific guidance.

Thursday, January 6, 2011

President signs food safety legislation

President Obama signed into law Tuesday legislation that represents the first major overhaul of the nation's food-safety infrastructure since 1938.

The Food Safety Modernization Act moves the FDA away from its previous role of responding to adulterated food to a more modern one of requiring companies to stop contamination before it happens by looking for the places where things can go wrong and fixing them.

The Act also allows the agency to issue mandatory recalls and hire more food-safety inspectors.

The FDA will need to draft regulations to enforce the new law.


Some of the changes the Act puts into place:

Before Now
Surveillance Under the FDA's original statute from 1938, the focus was on responding to adulterated food once it was discovered. Under the new rules, the FDA's focus shifts to stopping outbreaks before they start, by requiring farmers to address places in production where contamination might occur and to require processors to implement written food-safety plans.
Enforcement The FDA couldn't force a company to recall tainted food; it could only seek a voluntary recall. When needed, the FDA can order the recall of tainted food.
Specific targets The FDA had to treat all foods the same, despite the fact that some are more likely to become contaminated than others. FDA can develop regulations that focus on the highest-risk foods, including fruits, vegetables and imports.
Inspections The FDA was able to inspect fewer than 20% of domestic food facilities and 1% of foreign food imports. More than half of food facilities have gone five or more years without a federal inspection, according to a 2010 report from the Health and Human Services inspector general. The FDA will be able to hire 2,500 more field safety inspectors and food-safety experts by 2014 and increase substantially domestic and foreign inspections. The riskiest domestic facilities will be inspected every three years, beginning in 2015.
Records checks For most plants, when the FDA conducted an inspection, it could only require a spot check of what was happening that day. The FDA will have access to the food-safety plan, records and test results that are linked to the safety plan.
Exemptions Big and small farms and producers were treated the same under the statute. Farmers who primarily sell to farmers' markets or to restaurants, and who sell less than $500,000 a year, don't have to follow the new regulations.

Wednesday, December 15, 2010

Dannon fined for making health claims for its yogurt product

The Dannon Company will pay a $21 million fine and stop making exaggerated health claims for two very popular Dannon products under an agreement with the federal government and attorneys general from 39 states.

Dannon will stop claiming that one daily serving of Activia yogurt relieves irregularity and that its DanActive dairy drink helps people avoid catching colds or flu, the Federal Trade Commission announced on Wednesday.

"These types of misleading claims are enough to give consumers indigestion," says FTC Chairman Jon Leibowitz. "Companies like Dannon shouldn't exaggerate the strength of scientific support for their products."

The move signals a more aggressive federal watchdog roll over deceptive advertising practices by major marketers under the Obama administration
The FTC charged that Dannon's ads were deceptive because it did not have substantiation for its claims. The commission also charged that Dannon's claims that Activia and DanActive were clinically proven were false.

The FTC complaint and settlement can be downloaded from the FTC website at: http://www.ftc.gov/opa/2010/12/dannon.shtm

Here are some tips on substantiation of product claims: http://business.ftc.gov/documents/substantiation-science-compliance.