Bipartisan Support for Embryonic Stem Cell Legislation

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On June 24, 2011, United States Representatives Diana DeGette (D-CO) and Charlie Dent (R-PA) introduced the bipartisan Stem Cell Research Advancement Act of 2011 (the “Bill”). The Bill would give legislative backing to President Obamas 2009 Executive Order allowing federal funding for medical research using discarded embryos from fertility clinics. Critics of the Bill argue, based on religious and moral grounds, that the research destroys viable embryos to harvest the stem cells. However, Representative Dent stressed that the Bill establishes important ethical criteria for stem cell research.

The Bill provides that in order to be eligible for federal funding, research must exclusively involve leftover embryos that would otherwise be discarded. Donors would also have to sign written consent forms and would be barred from receiving financial compensation. In addition, the Bill codifies the National Institutes of Health Guidelines (the “Guidelines”) for carrying out both embryonic and adult stem cell research.

Supporters of the Bill want to ensure that critical research can be conducted unimpeded by political interference. Currently, there are two human trials already underway for the treatment of spinal cord injuries and degenerative eye diseases using embryonic stem cells. See our previous reports here and here for more information on the embryonic stem cell trials.

Fuerst Ittleman will continue to monitor the Bill as it is up for vote in the House. For more information on Fuerst Ittlemans experience handling the FDA regulatory framework regarding stem cells, drugs, and biologics, please contact us at contact@fidjlaw.com.

Seven Major Pharmaceutical Companies File Citizen Petition Seeking FDA Guidelines Regarding Off-Label Information

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On July 5, 2011, seven large pharmaceutical manufacturers filed a citizen petition with the U.S. Food and Drug Administration (FDA) asking the Commissioner to “clarify FDA regulations and policies with respect to manufacturer dissemination of information related to new uses of marketed drugs and medical devices.” This citizen petition is an effort by pharmaceutical companies to push the FDA to clarify unresolved issues related to requests for off-label information, use of third-party clinical guidelines, and communication about off-label uses. Allergan, Eli Lilly & Company, Johnson & Johnson, Novartis Pharmaceuticals, Novo Nordisk, Pfizer, and Sanofi-aventis U.S. all signed this citizen petition.

The lawyers representing these pharmaceutical companies explained that the “current state of regulatory guidance is not clear or comprehensive” and “places manufacturers at risk of criminal and civil sanctions if they cannot correctly guess where the government would draw a line [on information about off-label uses]”. The citizen petition claims that despite the industrys efforts to piece together the agencys position from Federal Register documents, guidance, letters, and similar pronouncements, the FDAs vague language continues to create significant obstacles for stakeholders. Absent clear guidance or rules from the FDA, individual manufacturers have had to resort to inferring operative law and “what they believe is the correct interpretation” from the Agencys materials. As a result, “each individual manufacturer may either over- or under-communicate clinically relevant information, with significant attendant consequences for the public health.”

The citizen petition requests the FDA accept the following proposals:

  • Manufacturer Responses to Unsolicited Requests”The FDA should promulgate binding regulations embodying the FDAs current policy on responses to unsolicited requests, assure the policy affords manufacturers a balance between prohibiting off-label promotion and allowing appropriate dissemination of information related to off-label uses, and clearly distinguish a non-promotional response to an unsolicited request from product promotion.
  • “Scientific Exchange””The FDA should clarify its position on scientific exchange. In particular, to qualify as a “scientific exchange” statements must 1) make clear that a use or product is not FDA-approved or FDA-cleared, 2) make no claims that a use or product has been proven to be safe or effective, and 3) be truthful and non-misleading when measured against available information on the use or product.
  • Interactions with Formulary Committees, Payors, and Similar Entities”The FDA should address whether, and to what extent, economic or other product-related information may be shared with payors.
  • Dissemination of Third-Party Clinical Practice Guidelines”The FDA should address whether, to what extent, and when a manufacturer can disseminate third-party clinical practice guidelines when the guidelines are 1) developed by nationally recognized scientific medical organizations or agencies, 2) reproduced in similar format as the original publication, 3) reproduced by the manufacturer to include all products with the same indication, and 4) accompanied y relevant disclaimers and disclosures.

The manufacturers argue that in addition to helping pharmaceutical companies in their day-to-day decision-making, clearer guidelines would help to better safeguard the public health. These guidelines would help manufacturers better understand how to provide physicians information about risks of medical product use, which would help guide physicians in their treatment of patients. By filing this petition, “we think [it] is an important step in making the marketing rules more transparent” and “[e]nhanced transparency will be helpful to all stakeholders,” said one of the lawyers who worked on the petition.

Fuerst Ittleman will continue to monitor the progress of the FDAs response to concerns regarding off-label use. For more information, contact us at contact@fidjlaw.com.

House Representatives Propose New Safe Cosmetics Act

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On June 24, 2011, three members of the House of Representatives announced their support of the Safe Cosmetics Act of 2011 (the “Act”), which calls for stricter FDA oversight of cosmetic products. The Act is similar to a previous bill proposed in 2010 but has been modified in response to concerns from small businesses. The main proponents of this proposed legislation are Representatives Jan Schakowsky of Illinois, Ed Markey of Massachusetts, and Tammy Baldwin of Wisconsin.

The Act aims to curb use of harmful ingredients in cosmetics products by establishing stringent labeling requirements and authorizing the FDA to oversee the registration and regulation of cosmetics companies. While the FDA does have regulatory authority over cosmetic products and cosmetic ingredients, the FDA does not pre-approve these products or ingredients before they are placed on the market. The FDA only requires premarket approval for color additives. Cosmetic companies may voluntarily enroll in the FDAs Voluntary Cosmetic Registration Program, a post-market reporting system, but are not otherwise required to register their products with the FDA. Even though the FDA does not issue premarket approvals for cosmetic products, the FDA may pursue enforcement action against products or firms that violate the law.

The Campaign for Safe Cosmetics claims that over 12,500 unique chemical ingredients are used in personal care and cosmetics products, many of which have not been required to undergo any type of formal safety assessments. Supporters of the new Act believe the $50 billion industry needs to be held accountable to the public for the products they release into the market. “The growing number of reports of serious health problems arising from the use of dangerous chemicals in personal care products show a need to update our laws and protect men, women, and children from harmful exposure,” said Representative Schakowsky.
The main provisions in the Safe Cosmetics Act of 2011 are as follows:

  • Post Market Testing: the Secretary of Health and Human Services would be required to institute procedures for post market testing.
  • Registration of Cosmetic Companies and Registration Fee: Cosmetic companies would be required to register with the FDA and pay a registration fee based on annual gross receipts or sales.
  • Cosmetic and Ingredient Testing and Safety: the FDA would establish a list of prohibited ingredients for use in cosmetic products.
  • Market Restrictions: the FDA would be granted authority to recall products that are misbranded, adulterated, or otherwise fail safety requirements.
  • Mandatory Reporting of Adverse Health Effects: the cosmetic industry would be subject to mandatory reporting of adverse health effects.
  • Worker Issues: products for salon use would be required to indicate any related health hazards.
  • States Rights: states would have authority to set more stringent standards.

“The Safe Cosmetics Act will close a gaping hole in the federal law that allows potentially toxic chemicals to remain in the cosmetic products we use every day,” said Representative Markey. According to the Campaign for Safe Cosmetics, Americans use an average of 10 personal care products each day, which results in exposure to approximately 126 unique chemicals. The Act seeks to protect the publics health and safety by preventing products with unsafe ingredients from entering the market or granting the FDA authority to order manufacturers to cease production. In light of the growing number of reports about unsafe cosmetic products, supporters of the new legislation hope that this Act will provide the necessary steps to secure the publics safety against cosmetic products on the market.
Fuerst Ittleman will continue to monitor the progress of the Safe Cosmetics Act of 2011. For more information, please contact us at contact@fidjlaw.com

FDA to Hear Avistan’s Appeal Regarding Proposed Revocation of Drug Approval

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On June 28 – 29, 2011, Genentech appeared before the U.S. Food and Drug Administration (FDA) asking the Agency to reconsider its proposal to revoke Avastins approval for use in the treatment of breast cancer patients. The FDA approved Avastin three years ago through an accelerated approval process because Avastin is used to treat serious diseases and fills an unmet medical need. This accelerated approval process provides patients access to promising new drugs for treatment of serious or life-threatening conditions while awaiting the results of phase IV confirmatory clinical trials. If subsequent clinical trials fail to confirm the drugs clinical benefit, the FDA may take action to remove the drug from the market, see 21 C.F.R. § 314, subpart H. This marked the first time the FDA has held a hearing to consider a companys appeal of such a decision.

In February 2008, the FDA granted accelerated approval of Avastin for treatment of patients with breast cancer. The results of the initial clinical trial showed that patients treated with both Avastin and paclitaxel (chemotherapy) had a five and a half-month delay in the growth of their tumors when compared to patients who received paclitaxel alone. In spite of the fact that the clinical trial failed to provide evidence of prolonged life expectancy, the FDA granted drug approval.

Since then, the makers of the drug have conducted at least four clinical trials using Avastin in conjunction with other chemotherapy drugs. The results of these trials showed a much smaller delay in tumor progression, ranging from less than one month to approximately three months, and virtually no improvement in survival. In addition to the minimal improvement in a patients prognosis, Avastins side effects include bowel perforation, hemorrhaging, and organ damage or failure. Concerned that the drugs risks outweighed its benefits, the FDA convened the Oncologic Drugs Advisory Committee last year to vote on whether Avastins drug approval should be revoked. By a vote of 12 to 1, the panel moved to revoke Avastin’s approval for use in breast cancer treatment.

The FDAs decision has been a controversial one. Avistan is the worlds best-selling cancer drug, with revenues as high as $7 billion a year. Without FDA approval for use in treatment of breast cancer, Genentech could lose as much as $1 billion in annual sales. Even if Avastin loses its FDA approval here, the drug will continue to remain on the market because it is approved for treatment of other types of cancer and physicians can continue to prescribe Avastin off-label for breast cancer patients.

Many who oppose the FDAs decision are not placated by this alternative because insurance companies are unlikely to cover the costs of off-label prescriptions. For breast cancer patients who wish to continue using Avastin, these out-of-pocket costs could reach as high as $90,000 per year. Some even claim that the FDAs action may be the beginning of a slippery slope toward rationing of medication. FDA-supporters, however, are lobbying their concerns for public safety. Patient advocates assert that the FDA has a responsibility to remove Avistan from the market because cancer patients should only receive drugs that are proven effective for treatment.

Upon completion of the two-day hearing on June 29, 2011, the Oncologic Drugs Advisory Committee unanimously voted to revoke Avastins FDA approval for breast cancer treatment. The advisory committee also rejected Genentechs proposed compromise to keep the drug on the market while the company completes another phase IV clinical trial, which could take several years to complete. Genentech argued that despite the decrease in the delay of tumor growth exhibited in the clinical trials, Avastin still positively benefits breast cancer patients. After reviewing the data derived from these trials, however, the advisory committee was unconvinced that the drug significantly prolonged womens lives or improved the quality of their lives. Even though the committees decision is not final, the unanimous vote makes it seem more likely that FDA Commissioner Margaret Hamburg will move to rescind Avistans FDA approval. A final decision will not be made until after July 28, 2011, the close of the public comment period.

Fuerst Ittleman will continue to monitor developments in the FDAs regulation of drugs. For more information, contact us at contact@fidjlaw.com.

Supreme Court Holds Failure to Warn Suits Against Generic Drug Manufacturers Are Preempted By Federal Law

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On June 23, 2011, the Supreme Court ruled in Pliva, Inc. v. Mensing that federal law preempts state tort law suits against generic drug manufacturers for failure to provide adequate warning labels. The decision comes two years after Wyeth v. Levine in which the Court held that federal drug laws did not preempt such suits against brand-name manufacturers. As a result of its decision in Pliva, generic drug manufacturers have greater protection against state tort suits than their brand-name manufacturing counterparts. Also, as a result of this decision, consumers are left with fewer remedies for injuries caused by taking generic drugs than their brand-name counterparts.

In Pliva, Mrs. Mensing and Mrs. Demahy brought state-law tort claims against generic manufacturers claiming that the labels warning of the dangers associated with the long term use of their drugs were inadequate. As a result of the long term use of the generic drugs, Mrs. Mensing and Mrs. Demahy alleged that they developed a severe neurological disorder whose risk of development was known by the generic manufacturer to be greater than that indicated on the label.

Responding to the plaintiffs’ claims, the generic manufacturers argued that because federal law requires a generic drug to bear the same label as its brand-name counterpart, it was impossible to also comply with a state law duty to revise its labels. Thus, the Court addressed “whether federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus preempt, these state-law claims.”

In determining conflict preemption applied and that Mrs. Mensing’s and Mrs. Demahy’s state tort law claims were barred, the Court focused its analysis on “whether the private party could independently do under federal law what state law requires of it.” The Court found that under federal law brand-name and generic drug manufacturers have different labeling duties. While a brand-name manufacturer is responsible for the accuracy and adequacy of its label, a generic manufacturer’s duty is to ensure that its warning label is the same as the brand-name drug’s.

Consequently, the Court rejected the victims’ argument that, like the brand-name manufacturers in Wyeth, generic drug manufacturers could provide additional warning labels before receiving agency approval through the FDA’s “change being effected” (“CBE”) regulations. In reaching this conclusion, the Court relied heavily upon the FDA’s interpretation of its CBE regulations. The FDA asserted, and the Court agreed, that the CBE regulations only permit generic drug manufacturers to change its label: 1) to match an updated brand-name label, or 2) to follow the FDA’s instructions.

Furthermore, though all manufacturers bear responsibility for the content of their labels at all times to ensure adequate and accurate labeling, the “requirement of sameness” in generic labeling prohibits the unilateral change of a generic label. Instead, the Court adopted the FDA’s position that “generic drug manufacturers that become aware of safety problems must ask the [FDA] to work toward strengthening the label that applies to both the generic and brand-name equivalent drug,” rather than unilaterally changing a label.

However, the Court also rejected the argument that in order for state tort claims against manufacturers of generic drugs to be preempted by federal law, the generic drug manufacturer must first ask the FDA for help in strengthening the brand-name label and thus its own. In rejecting this argument, the Court found that even if a generic drug manufacturer complied with its obligation under federal law to communicate with the FDA about the possibility of a safer label, such actions would not satisfy its state law duty to provide adequate labeling. The Court stated: “state law demanded a safer label; it did not instruct the Manufacturers to communicate with the FDA about the possibility of a safer label.” The Court went on to hold that “when a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for preemption purposes.”

Therefore, because state tort law requires all drug manufacturers to  adequately and safely label their products, but federal drug regulations prevent generic manufacturers from unilaterally changing their generic drug products’ safety labels, “it was impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same.” As such, the Court found that state law was preempted by the federal drug regulatory regime.

Given that the Court previously found in Wyeth that “Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness,” this case raises the interesting question of whether the Court’s decision leaves a gap in consumer protection. The practical result of the Court’s opinion is that the ability of an individual to bring a state tort suit for failure to warn of dangers regarding drug products now hinges on whether that drug product is brand-name or generic. However, the Court’s last line of Pliva is telling: “as always, Congress and the FDA retain the authority to change the law and regulations if they so desire.” Fuerst Ittleman will continue to monitor the progress of these issues. For more information, contact us at contact@fidjlaw.com.

GAO Recommends Increased FDA Oversight of Medical Device Recalls

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On June 14, 2011, the U.S. Government Accountability Office (GAO) released a new report on the U.S. Food and Drug Administration’s (FDA) oversight of medical device recalls. The report determined that the FDA’s current system for reviewing medical device recalls does not satisfactorily guarantee the removal of unsafe medical devices from the market.

In this report, the GAO discussed how the FDA uses information derived from medical device recalls to aid its oversight. The GAO analyzed data from a sample of medical devices that were recalled between 2005 and 2009. The report identified several deficiencies in the FDA’s current system and recommended that the FDA 1) develop enhanced procedures and criteria for assessing the effectiveness of recalls, 2) document the agency’s basis for terminating individual recalls, and 3) routinely assess information on device recalls. The U.S. Department of Health and Human Services (HHS) agreed with the GAO’s recommendations.

Even though medical device recalls are typically initiated by the firm that manufactured the device, the FDA is responsible for overseeing the implementation of a recall. Over 3,500 medical device recalls were initiated over the five-year period under scrutiny in the report.  In addition to its unclear procedures for overseeing recalls, the report indicated that the FDA lacks established criteria for assessing whether firms corrected or removed an appropriate number of devices from the market. Without clear guidance or criteria for recall termination, the FDA frequently exceeded its own prescribed timeframe when making decisions and failed to provide documentation as to how it reached those termination decisions. As a result of the FDA’s vague regulations and processes, FDA officials examining similar recall situations often reached opposite conclusions on the efficacy of a firm’s recall efforts. 

The GAO report also found that the FDA does not regularly analyze its own recall data to identify recurring trends or problems with medical devices. This is a “miss[ed] opportunity to use recall data to proactively identify and address the risks presented by unsafe devices,” the GAO report stated. Senators Chuck Grassley of Iowa and Herb Kohl of Wisconsin are strongly pushing for the FDA to establish periodic reviews of medical device recall data. Senator Grassley explained that “patients would be better served if the FDA took a thorough approach to post-market surveillance of medical devices” because early identification of dangerous devices would “establish greater accountability for patients.”

The FDA’s ability to analyze existing data for clues about potentially hazardous medical devices is particularly important in light of the FDA’s new Medical Device Innovation Initiative. As we reported earlier this year, the FDA launched an accelerated review program for “new, breakthrough medical devices.” Installing review procedures of recall data provides the FDA with an opportunity to regain leverage in the scientific community. Understanding where older devices were inadequate or flawed places the Agency in a better position to make better decisions about future medical devices. This review process can also help keep the FDA from falling too far behind the rapidly evolving scientific community.  

The GAO’s report comes less than a month after the GAO issued a report urging the FDA to make changes to its seafood oversight program, as we reported here. Together, these reports highlight significant weaknesses in the FDA’s regulatory scheme, which have direct implications on public safety and health.

Although Americans continue to demand more improvement from the FDA, it is less clear whether the Agency can implement any real changes. As we reported here and here, the significant decrease in the FDA’s funding may impede the Agency’s ability to institute change.
Fuerst Ittleman, PL will continue to monitor the developments in the FDA’s medical device oversight program. For more information, contact us at contact@fidjlaw.com.

Cuts in Food Safety Funding

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After three days of a full floor debate, the U.S. House of Representatives approved the 2012 Agriculture Appropriations Bill on June 16, 2011. The bill proposes significant cuts to the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) budgets for food safety programs.

President Obama requested a 30 percent increase of the FDA budget in order to implement the changes required by the Food Safety and Modernization Act (FSMA). As we previously reported, the FSMA expands the powers of the FDA. However, the appropriations bill reduces the FDA food safety budget by $87 million from last year – nearly $205 million less than the President requested. As a result, food safety advocates are concerned that the budget reductions could seriously harm the FDAs ability to protect the U.S. food supply. Without adequate funding for FDA food safety programs, foodborne illness rates could rise.

The appropriations bill also cut the USDA budget for the Food Safety Inspection Service (FSIS) by $88 million, which is an 8 percent reduction from the 2011 budget. Because the FSIS budget primarily funds personnel, advocates worry there will be fewer inspections for meat, poultry, and processed eggs. The administration said cuts to food inspection may require the agency to furlough frontline food inspectors. Consequently, farmers and ranchers will have to continue to feed their livestock while they wait for inspection in order to receive the USDA seal of approval for slaughter. Budget cuts would also threaten small processing plants that rely on the stream of inspections for production. As a result of fewer inspections, consumers are likely to see an increase in prices and the risk of contaminated food.

Additionally, the House amended the appropriations bill to prohibit the FDA from approving the sale of genetically engineered (GE) salmon. Critics, concerned that the sale of GE salmon will threaten the salmon fishing industry of coastal states, question whether the fish is safe for human consumption. For more information on the approval of genetically engineered salmon, please see our previous report.

Fuerst Ittleman will continue to monitor the Senate version of the bill. For more information contact us at contact@fidjlaw.com.

FDA Releases Final Citizen Petition Guidance for Section 505(q)

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On June 8, 2011, the U.S. Food and Drug Administration (FDA) announced the release of the final guidance document regarding citizen petitions subject to section 505(q) of the Federal, Food, Drug, and Cosmetic Act. Section 505(q), which was added by the FDA Amendments Act (FDAAA), states that the FDA shall not delay approval of pending Abbreviated New Drug Applications (ANDAs) for generic drugs as a result of citizen petitions that request FDA action.

Section 505(q) was designed to help prevent sham petitions, which are citizen petitions typically submitted to the FDA by pharmaceutical companies which hold patents to brand-name drugs in order to intentionally delay the approval of ANDAs submitted by manufacturer of generic versions.

The final guidance document outlines how the agency will treat petitions believed to be shams. The guidance details: (1) how section 505(q) applies to a particular citizen petition; (2) whether a petition would delay the approval of a pending ANDA; (3) the certification requirement; and (4) the verification of supplemental information.

Citizen petitions, including communication with the FDA intended to delay approval, must be submitted in writing pursuant to § 10.30 or § 10.35 and filed as comments in the appropriate docket. However, section 505(q) does not apply to petitions that could not under any reasonable theory delay the approval of a pending application, or to petitions submitted before September 27, 2007. Additionally, for section 505(q) to apply, the petition must concern a pending application at the time of submission.

A petition that meets the provisions of section 505(q) may not delay the approval of a pending application unless the FDA determines that a delay is necessary in order to protect the public health. The FDA provided two examples of public health issues that could necessitate a delay of the application: (1) whether a proposed generic drug is bioequivalent to the reference listed drug, and (2) whether an indication can be safely omitted from the labeling because the indication is patent protected. The FDA will evaluate if a petition delays the pending application by addressing whether the application would be ready for approval but for the issue(s) raised in the petition.

Pursuant to section 505(q), a petition must be certified by the petitioner to be considered for review by the FDA. The purpose of the certification is to ensure that the petitioner has disclosed all relevant information, both favorable and unfavorable, and verified the information is accurate. If the petition fails to include the exact language of the certification or complete date, the petition will not be reviewed. If a petitioner mistakenly submits a petition without the complete certification statement, he must submit a letter withdrawing the deficient petition and submit a new petition. The 180-day timeframe for the FDA response will begin upon submission of the new petition.

According to the final guidance document, the FDA timeframe to respond to a citizen petition could be tolled if the petition requests the FDA to take an action related to a specific aspect of a pending ANDA for which there is no final decision. A FDA response to a citizen petition should not interfere with an ANDA as a whole; therefore, a response may be issued beyond the timeframe if the petition is related to specific aspects such as a proposed trade name or specific claims proposed in the labeling.

We will continue to monitor the effects of the new citizen petition guidance and section 505(q). For more information contact us at contact@fidjlaw.com.

FDA’s New “Pathway” to Improved Monitoring of Food and Drug Imports

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Amid growing concerns over the safety of food and drug imports into the country, the U.S. Food and Drug Administration (FDA) recently released a plan to improve oversight and regulation of imported goods. The “Pathway to Global Product Safety and Quality” is part of the FDAs “new global strategy” under the Food Safety Modernization Act (FSMA) to monitor and inspect an increasing number of imports that cross into U.S. borders.

The FDA is responsible for overseeing the food, pharmaceutical and medical device products that enter into U.S. territory, as well as regulating the manufacturers and importers who produce these goods. The movement towards globalization and increased flow of capital, information, and goods across borders have put a strain on both the FDAs resources and ability to efficiently and effectively regulate the importation of goods. Over the next year alone, the FDA projects the number of shipments of FDA-regulated goods that will pass through the nations 300 ports of entry is expected to quadruple from 6 million to 24 million shipments.

This heavy influx of imported, globally-sourced goods has effectively created a regulatory nightmare for the FDA. In todays market, a product may move through different manufacturers or suppliers in multiple countries before reaching its final product stage or destination. Because goods are now entering the U.S. from new and different markets, the FDA is faced with the challenge to ensure that all entities in that multi-step chain comport with FDA regulations. The FDAs ability to sustain adequate regulatory functions has been impaired by these challenges.

In recent years, evidence of the FDAs struggle to keep up with the monitoring and regulation of imports has reached the publics eye. The New York Times published an article highlighting the FDAs failure to remove dangerous imported foods from the market. The article explained how the FDA failed to execute required audits or follow-up with companies about known contaminated food imports. Other events, such as heparin poisoning by a manufacturer, milk contamination, and counterfeit glucose monitoring strips, have put a spotlight on how the FDA has fallen short of its regulatory goals. As we blogged here earlier this year, the President even warned the FDA that it would likely be the target of a major overhaul due to its outdated processes and failure to keep up with advances in the rapidly changing market.

The new “Pathway to Global Product Safety and Quality” is the FDAs response to these mounting problems related to the importation of food and medical products. Under the FSMA, the FDA has a new mandate to require comprehensive, prevention-based controls. In addition, the FDA can now hold importers responsible for making sure that their foreign suppliers have adequate preventive controls to ensure the safety of foods shipped to the U.S. The FSMA also directs the FDA to inspect at least 600 foreign food facilities within the next year and to double the number of inspections every year for the next five years.

To help with the regulation of the medical device industry, the FDA has opened additional offices in key international locations and increased its number of foreign inspections. The FDA has also engaged in harmonization of drug regulation through the International Conference on Harmonization. In addition to working with Australia to create the Global Harmonization Task Force to expand the global regulation forum, the FDA also joined the Pharmaceutical Inspection Cooperation/Scheme (PIC/S), which is an informal organization of drug manufacturing inspectorates from 39 countries.

As part of its transformation “from a domestic agency operating in a globalized world to a truly global agency fully prepared for a regulatory environment in which product safety and quality know no borders,” the FDA is in the process of developing an international operating model as part of the new “Pathway to Global Product Safety and Quality” plan. The four tenets of this approach are:

  1. The FDA, in close partnership with its foreign counterparts, will assemble global coalitions of regulators dedicated to building and strengthening the product safety net around the world.
  2. With these coalitions, the FDA intends to develop a global data information system and network in which regulators worldwide can regularly and proactively share real-time information and resources across markets.
  3. The FDA will continue to expand its capabilities in intelligence gathering and use, with an increased focus on risk analytics and thoroughly modernized IT capabilities.
  4. The FDA will effectively allocate agency resources based on risk, leveraging the combined efforts of government, industry, and public- and private-sector third parties.

This operating model aims to provide the FDA with the information sharing and technological tools necessary to regulate a global market and to ensure the safety of Americans.

The FDAs new, extensive global plans raise serious questions about implementation. Even though these plans demonstrate that the FDA recognizes the deficiencies in its current scheme and understands what needs to be done to improve the regulation of imported goods into the U.S., these plans hardly seem feasible. For example, under the current model, the FDA has had difficulties inspecting a few hundred facilities annually, yet the Agency is expected to execute 19,200 food facility inspections in the plans sixth year. Without significant increases to agency personnel or third-party contractors and the threat of a smaller budget this fiscal year, the FDA seems to lack the manpower and resources to accomplish the goals set forth by the FSMA and in the new “Pathway to Global Product Safety and Quality” plan. The FDA does acknowledge in its new plan that it “does not”nor will it”have the resources to adequately keep pace with the pressures of globalization” and that constrained federal resources will prove challenging to the fulfillment of its goals. Even if the new global initiatives are successful in alleviating some of the FDAs current problems, it is still unclear as to whether the FDA will be able to implement any changes that produce discernible results or increased protection of the publics safety.

Fuerst Ittleman will continue to monitor the FDAs progress regulating the importation of foods and devices. For more information, please contact us at contact@fidjlaw.com.

FDA Issues Final Rule On Cigarette Warnings And Unveils Nine New Graphic Warning Labels

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On June 21, 2011, the FDA released nine new graphic warning labels that will be required to appear on every pack of cigarettes sold in the US and in every cigarette advertisement starting no later than September 2012. A copy of the Department of Health and Human Services press release can be read here.

As we previously reported, with the passage of the Family Smoking Prevention and Tobacco Control Act, (“Tobacco Act”) Congress granted the FDA the authority to regulate all tobacco products marketed within the United States. As part of this expansion of FDA jurisdiction, Congress required the FDA to establish nine new larger and more noticeable textual warning statements to appear on all cigarette packaging and in all advertisements. The act also required the FDA to develop and implement regulations requiring that graphic color images depicting the negative health consequences of smoking go together with each new warning statement. The new warning labels can be viewed on the FDAs website.

The new regulations require that by September 2012, the new cigarette warning labels and incorporated graphic images must appear on the top half of both the front and rear panels of each cigarette package to replace the current warnings which appear on cigarette packaging. Additionally, the regulations require that these warnings and images appear in the upper portion of each cigarette advertisement and occupy at least 20 percent of the total area of the advertisement. A copy of the final rules regarding cigarette warning labels can be read here.

Since its passage, the Tobacco Act has been the subject of numerous lawsuits by tobacco manufacturers challenging several of its key provisions. As we previously reported, in February of 2011, two menthol cigarette manufacturers, Lorillard and R.J. Reynolds filed suit to block the FDA from implementing the recommendations of the Tobacco Products Scientific Advisory Committee regarding the prohibition of sale of menthol cigarettes. The suit alleges that the committee cannot provide fair advice because three of its members have conflicts of interests, which are expressly prohibited under the Tobacco Act.

Additionally, prior to the adoption of final rules regarding new warnings labels, tobacco manufacturers filed suit alleging that the requirement of new warning labels, as well as the ban on color and graphics on future packaging and advertisements, violated the manufacturers right to free speech under the First Amendment. The United States District Court for the Western District of Kentucky found that the Tobacco Acts “blanket ban” on all uses of color and images in tobacco labels and advertisements was not sufficiently narrowly tailored to survive and therefore violated the First Amendment. However, the Court went on to find that the warning labels requirement is “sufficiently tailored to advance the governments substantial interest” in protecting public health and thus does not violate the First Amendment.

It is important to note that tobacco product regulation in the United States also involves the U.S. Customs and Border Protection (CBP) and the U.S. Department of the Treasury, Alcohol, Tobacco, Tax and Trade Bureau (TTB). Additionally, the Department of Justice, Office of Consumer Protection Litigation (OCPL) regulates Cigarette labeling and advertising, and the Bureau of Alcohol, Tobacco, and Firearms (ATF) investigates and enforces interstate trafficking of contraband cigarettes. State laws may also be implicated.

Experienced attorneys at FI can help establish calculation of duty including excise taxes and user fees, ensure compliance with invoice, permit, and recordkeeping requirements, ensure legal labeling and product packaging and defend against administrative actions and litigation. If you have questions pertaining to the FDCA or the Tobacco Act or how to ensure that your business maintains regulatory compliance at both the state and federal levels, contact Fuerst Ittleman PL at contact@fidjlaw.com.