A New York state court struck down today the New York City regulation that would have limited the size of certain “sugary drinks” to 16 ounces at select food service establishments. Initially proposed by Mayor Bloomberg’s Office and ultimately adopted by the New York City Board of Health, the ban was scheduled to begin at midnight tonight.
The court held that the enactment of the rule violated the New York Constitution because it was passed by an administrative agency, the Board of Health, rather than the city’s legislative body, the City Council. Petitioners challenging the rule argued that the Board of Health exceeded its authority and “impermissibly trespassed on legislative jurisdiction” by passing the rule, while the City contended that the rule was properly passed pursuant to the Board’s broad authority to regulate matters affecting public health. In finding that the Board exceeded its authority, the court wrote that “[t]he Portion Cap Rule, if upheld, would create an administrative Leviathan and violate the separation of powers doctrine.”
The court further held that the rule was arbitrary and capricious because it irrationally applies to some but not all food establishments, and excludes certain “beverages that have significantly higher concentrations of sugar sweeteners and/or calories on suspect grounds.” Mayor Bloomberg immediately expressed his disagreement with the decision and indicated that the city intends to appeal.
This is a follow-up to our post late last year on the Second Circuit decision in US v. Caronia, which overturned a defendant’s off-label marketing conviction on First Amendment grounds (see our December 10, 2012 post, “Second Circuit Overturns Off-Label Marketing Conviction On First Amendment Grounds”). In United States v. Harkonen, the Ninth Circuit rejected the defendant’s First Amendment argument, and affirmed wire fraud convictions.
Here is a little background on the case. W. Scott Harkonen was the CEO of InterMune. InterMune manufactured a drug, Actimmune, which was approve for treatment of chronic granulomatous disease (CGD) and severe, malignant osteopetrosis. Harkonen was accused of causing InterMune to issue a press release which was false and misleading regarding Actimmune’s efficacy in treating idiopathic pulmonary fibrosis (IPF), for which it was not approved. A jury convicted him of mail and wire fraud, but acquitted him of FDCA misbranding charges.
On appeal, Harkonen argued that the press release was protected speech under the First Amendment. The Ninth Circuit rejected Harkonen’s argument. The Court applied a two-step analysis: (1) “deferring to the jury’s findings . . . we ask whether the evidence supports the verdict; and (2) if it does, we determine whether the facts, as found by the jury, establish the core constitutional facts.” The Court explained that because under United States v. Alvarez (132 S.Ct. 2537, 2544 (2012) “[t]he First Amendment does not protect fraudulent speech,” “the core constitutional issue” was “whether the facts the jury found establish that the Press Release was fraudulent.”
The Ninth Circuit found that there was sufficient evidence to find that the press release in question was fraudulent, and was thus not protected by the First Amendment. Because Harkonen was convicted of wire fraud and not misbranding, the Ninth Circuit did not have occasion to revisit the Second Circuit’s decision in United States v. Caronia. However, since the government chose not to appeal Caronia, it might be fair to ask in light of Harkonen whether in future prosecutions the government will strain to find ways to include mail and wire fraud offenses in pharma investigations and thus avoid Caronia’s effect altogether.
As required by Congress under the Food Safety Modernization Act, the Food and Drug Administration (FDA) released its International Food Safety Capacity-Building Plan on February 28, 2013. The plan outlines how the FDA intends to expand the technical, scientific, and regulatory capacity of foreign governments over the next five years.
The plan describes four key goals:
- ensuring efficiency across the Foods and Veterinary Medicine Program,
- increasing effectiveness through evidence based decision making,
- supporting the exchange of information between FDA and foreign government agencies or other entities, and
- enhancing technical assistance and capacity building in food safety.
As part of its international capacity building efforts, the FDA has also established foreign offices in seven regions, which we discussed last year.
On February 26, 2013, Energy and Commerce Committee Ranking Member Henry A. Waxman and Rules Committee Ranking Member Louise M. Slaughter introduced H.R. 820, the Delivering Antimicrobial Transparency in Animals (DATA) Act. The DATA Act would amend the federal Food Drug and Cosmetic Act to require sponsors of antimicrobial drugs to submit annual reports for each antimicrobial active ingredient in a drug that is sold or distributed for use in food-producing animals. The DATA Act would also require live poultry dealers, swine contractors, or feed lot operators who purchase, contract, or manufacture feed that contains a new animal drug to submit reports to FDA that detail, by food-producing animal, the amount of each microbial active ingredient contained in the feed and the quantity of feed sold or distributed for that animal.
In addition, the DATA Act would require the FDA to make publicly available summaries of the information it receives and to coordinate with the Department of Agriculture to expand and coordinate the collection of data on the use of antimicrobial drugs in food-producing animal species for use by the Animal and Plant Health Inspection Service and the Economic Research Service.
On February 13, 2013, the Institute of Medicine of the National Academies (IOM) released its report Countering the Problem of Falsified and Substandard Drugs. The report identifies causes and recommends strategies to address the problem of substandard and falsified drugs.
The IOM first distinguishes public health concerns of falsified and substandard drugs from the intellectual property concerns of counterfeit drugs, which the IOM narrowly defines to mean a drug that infringes on a registered trademark.
The IOM then identifies neglect of good manufacturing practices as the root cause of substandard drugs. Because incentives to produce substandard drugs are driven by market forces, the IOM recommends a number of market interventions intended to reduce such incentives. Such recommendations include private-sector assistance for responsible manufacturers in developing countries to meet international quality standards, and investment in pharmaceutical manufacturing in low- and middle- income countries by the International Finance Corporation and the Overseas Private Investment Corporation.
To address the problem of falsified drugs, the IOM recommends the following:
- restriction of the US wholesale market to firms vetted by the National Association of Boards of Pharmacy;
- government encouragement of private sector investment through low-interest loans, assistance with pharmacist training, and providing incentives to trained staff who remain in under served areas; and
- voluntary international agreements to strengthen surveillance systems, regulation, and enforcement by facilitating passage of national laws and permitting extradition of criminals responsible for falsified drugs and criminally negligent manufacture.
FDA Commissioner Margaret Hamburg stated that many of the recommendations in the IOM report support efforts already underway at the FDA, including strengthening global regulatory capacity and surveillance.
Last week, the Department of Justice brought a sweeping indictment against several former Peanut Corporation of America executives alleging egregious, and intentional, violations of food safety laws that caused the salmonella peanut outbreak of 2008. The government charged four individuals who allegedly directed the scheme in an indictment that contains 76 counts of conspiracy, wire fraud, mail fraud, violations of federal food and drug laws, and obstruction of justice. What is most significant in this case is the reach of the alleged violations and the number and management positions that were held by the former PCA employees that have been indicted in the case. Several features of the PCA case may well signal the government’s increased readiness to use criminal prosecutions to police violations of the nation’s food safety laws.
Click here for more on the far-reaching implications of this case and considerations for what may come under FSMA.
FDA issued a final rule yesterday that adopts, without change, the interim final rule, “Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption,” which was published on May 5, 2011 in the Federal Register. As required by the Food Safety Modernization Act (FSMA), the final rule implements revisions to the finding required in order for FDA to order administrative detention of human or animal food. Continue Reading
According to the 2013 unified agenda for the Department of Health and Human Services, FDA plans to recommend several changes to U.S. OTC drug labeling, safety monitoring, and manufacturing standards in 2013 which may impact future marketing and product development strategies for consumer products. Forthcoming FDA proposals include the following:
Proposed Monograph Modifications
- Amending the topical antiseptic monograph to address consumer hand wash products (February 2013);
- Amending the OTC monograph addressing cough/cold drug products containing an oral bronchodilator (ephedrine and salts) in combination with any expectorant or any nasal decongestant (March 2013);
- Modifying the cough & cold product monograph to address safety and efficacy issues associated with pediatric cough and cold products (June 2013);
- Modifying the cough & cold product monograph to add the common cold indication to certain OTC antihistamine active ingredients (June 2013);
- Amending the topical antiseptic monograph to address consumer leave-on antiseptic products (July 2013);
- Proposing rulemaking to address the safety of sunscreen active ingredients (July 2013);
- Amending internal analgesic product monograph to address acetaminophen safety (August 2013);
- Proposing rulemaking to address active ingredients for sunscreen reviewed under time and extent applications (September 2013); and
- Amending internal analgesic product monograph to address products marketed for children under 2 years old and weight- and age-based dosing for children’s products (December 2013).
Proposed Post-Marketing Safety Obligation Modifications
- Addressing post marketing safety requirements for combination products (combinations of a drug, device, and/or biological product), to clarify that a combination product is subject to the reporting requirements associated with the type of marketing application under which the product is approved, licensed, or cleared, and to certain additional, specified reporting requirements depending on the types of constituent parts (drug, device, or biological product) of which it is comprised (April 2013)
Proposed cGMP Modifications
- Amending regulations regarding the control over components used in manufacturing finished pharmaceuticals (May 2013); and
- Clarifying and codifying the current good manufacturing practice (cGMP) requirements for combination products (combinations of a drug, device, and/or biological product), to ensure consistency and appropriateness in the regulation of combination products and avoid the necessity to fully implement both drug cGMP regulations and device quality system regulations when manufacturing combination products (December 2013).
The cough/cold monograph amendments reflect collaboration under the U.S.-Canada Regulatory Cooperation Council (RCC). According to FDA, “the objectives of the RCC monograph alignment working group are to conduct a pilot program to develop aligned monograph elements for a selected over-the-counter drug category (e.g., aligned directions, warnings, indications, and conditions of use) and subsequently, develop recommendations to determine the feasibility of an ongoing mechanism for alignment in review and adoption of these OTC drug monograph elements.”
FDA also is expected to closely monitor monograph and firm registration compliance. Notably, the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, now requires drug firms to submit annual establishment registrations in the period from October 1st to December 31st of each calendar year. In addition, at the time of annual registration, firms must list any drugs not previously listed. Drug establishment registration information allows FDA to identify all manufacturing facilities involved in producing drugs that are in commercial distribution in the United States, and drug listing information helps the FDA maintain a catalog of all drugs in commercial distribution in the United States. Drugs that are manufactured in establishments that are not properly registered and drugs that are not properly listed as required are misbranded and may be subject to regulatory action.
On January 16, 2013, the Food and Drug Administration (FDA) announced the rate for the generic drug active pharmaceutical ingredient (API) and finished dosage form (FDF) facilities user fees for fiscal year (FY) 2013. The Federal Food, Drug, and Cosmetic Act (FDCA) as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA) authorizes FDA to assess and collect user fees for certain applications and supplements associated with human generic drug products, on applications in the backlog as of October 1, 2012, on finished dosage form (FDF) and active pharmaceutical ingredient (API) facilities, and on Type II API drug master files (DMF) to be made available for reference. GDUFA also directs FDA to establish each year the generic drug user fee rates for the upcoming year. In the first year of GDUFA (FY 2013), some rates will be published in separate Federal Register notices because of the timing specified in the statute. Each year thereafter the GDUFA fee rates will be published 60 days before the start of the fiscal year. FDA January 16 announcement established the FY 2013 rate for API and FDF facility fees, which are due on March 4, 2013.
More information regarding the Generic Drug User Fee Amendments of 2012 is available here.
FDA recently granted clearance to a new telemedicine product – the Welch Allyn iExaminer – which, when used in conjunction with the iPhone, allows users to capture, send, store, and receive high resolution images of the eye. According to the manufacturer’s 510(k) submission, the iExaminer is cleared for prescription use only and is intended to be used by trained personnel in a medical or school environment. Health professionals may use the images to assist in various ways, including assisting with diagnosis of eye conditions, sending the images to specialists, or saving the images as part of the medical record for future comparisons.
The iExaminer is not the first iPhone app to receive medical device clearance, which FDA is limiting to those applications that meet the definition of “medical device”. FDA previously cleared apps intended for use by medical professionals and consumers to measure blood pressure, view radiological images, and monitor blood glucose. FDA has expressed support for the benefits of applications in the health setting, but has cautioned that medical professionals and consumers must also be aware of the risks. In particular, the agency is concerned about apps that could pose a health risk to consumers and patients if they do not work as intended. FDA’s draft guidance for industry regarding medical mobile applications is available here.