FDA Announces Labeling Changes and Effectiveness Testing for OTC Sunscreen Products

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After decades of deliberation, the U.S. Food and Drug Administration (FDA) announced changes to the requirements for over-the-counter (OTC) sunscreen products. In 1978, the FDA began developing new rules for the regulation of sunscreen products. Now, over thirty years later, the FDA issued a Final Rule as part of its “ongoing efforts to ensure that sunscreens meet modern-day standards for safety and effectiveness” for sunscreens sold without a prescription. The FDA issued four regulatory documents: a Final Rule, a Proposed Rule, an Advance Notice of Proposed Rulemaking, and a Notice of Availability of Guidance Document for Industry (ANPR). The new requirements under the Final Rule will take effect by the summer of 2012.

After reviewing current scientific data, the FDA established a standard broad spectrum test procedure for OTC sunscreens and developed new labeling requirements for marketing sunscreen products. While the current rule focuses almost exclusively on protection against only ultraviolet B (UVB) radiation from the sun, the new Final Rule addresses protection against UVB rays and early skin aging and skin cancer caused by exposure to ultraviolet A (UVA) rays. This new standard broad spectrum test essentially measures the level of UVA radiation protection in relation to the amount of UVB radiation protection. Products are required to pass this broad spectrum test in order to be labeled as “Broad Spectrum” sunscreens. This new designation is intended to help consumers make more informed decisions when selecting sunscreens.

The new rule will also affect the labeling of “Sun Protection Factor” (SPF), the value that indicates the overall amount of protection provided by sunscreen, and claims for use. When used as directed, “Broad Spectrum” sunscreens with SPF values above 15 can help to protect against sunburn, skin cancer, and early skin aging. Under the FDAs new Rule, only these products may claim to reduce the risk of skin cancer and early skin aging if used as directed with other sun protection measures. Products with SPF values below 15, however, are prohibited from using “Broad Spectrum” on their labels and can only claim to help prevent sunburn.

In addition to “Broad Spectrum,” SPF, and use claims labeling, the Final Rule also outlines requirements for water resistance claims and “waterproof,” “sweatproof,” or “sunblock” claims. The new labeling rules will require manufacturers to indicate on the front label whether the sunscreen product is effective for 40 minutes or 80 minutes while swimming or sweating, or if the product is not water resistant, to direct consumers to use a water resistant sunscreen if swimming or sweating. The Rule provides that sunscreen manufacturers cannot label products as “waterproof,” “sweatproof,” or identified as a “sunblock” because these claims “overstate their effectiveness.” As part of the new labeling requirements, manufacturers will also be required to include drug facts on their labels, which will provide consumers with easy access to the products active and inactive ingredients and detailed directions on proper usage.

The FDA is also interested in obtaining additional information and data about sunscreen in other dosage forms, such as sprays, lotions, oils, sticks, gels, butters, ointments, creams, and pastes. The FDA seeks information about the safety and effectiveness of these alternative dosage forms of sunscreen because “the record (data and information) about sunscreens in spray dosage forms is not comparable to that for sunscreens in other dosage forms.” The ANPR serves as an invitation to the public to comment on regulations the FDA may pursue in its future rulemaking.

By creating regulations that require testing and limit misleading claims, the FDA has demonstrated its increased effort to strengthen labeling regulation of sunscreen products. Despite these improvements, some continue to question whether the FDA could have done more. Advocacy groups, like Environmental Working Group (EWG), continue to pressure the FDA to further tighten safety standards for sunscreen products sold in the United States. “The Agencys weak standard for UVA protection will not allow consumers to differentiate between superior and mediocre products,” a representative of EWG said. EWG claims that the FDAs rule is not stringent enough and that “about 20 percent of products that meet the new FDA standards could not be sold in Europe, where UVA standards are strict.” According to the FDA, however, “the ingredients in sunscreens marketed today have been used for many years and the FDA does not have any reason to believe these products are not safe for consumer use.” The FDA is currently reexamining the safety information available for active ingredients included in sunscreens marketed today.

The FDAs decision to make changes to the labeling and testing of sunscreen products comes less than one year after it released a Consumer Health Information publication warning about the dangers of exposure to devices such as sunlamps and tanning beds. As we reported here, the FDA announced its concern about the use of both UVA and UVB radiation in tanning salons because of the known risks associated with exposure, such as skin damage, early skin aging, and skin cancer. These concerns are the very same ones that prompted the FDA to make labeling changes to sunscreen products this year. While the FDA has yet to release new regulations governing sunlamps and tanning beds, the new changes to sunscreen product labeling may serve as an indication of the FDAs shift towards stricter oversight and regulation of products and devices associated with UVA and UVB exposure.

Fuerst Ittleman will continue to monitor the FDAs rules for labeling and effectiveness testing of sunscreen products and other products or devices related to UVA or UVB exposure. For more information, please contact us at contact@fidjlaw.com.

Researchers Continue to Look to Stem Cells for Clues for Effective Treatments of Orthopedic Trauma and Blood-Related Disorders

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This week, the scientific community announced two projects that may have important implications on the future of stem cell research and the development of effective treatments for orthopedic trauma and blood-related disorders. These projects signal a continued effort by researchers to improve our understanding of the bodys basic mechanisms for producing hematopoietic stem cells (HSCs), which are multipotent cells that have the ability to replenish all blood cell types. The U.S. Food and Drug Administration (FDA) regulates human cells or tissues intended for implantation, transplantation, infusion, or transfer into a human recipient, as well as the devices that process human cells and tissue. While the FDA has jurisdiction over these stem cells and has provided some guidance for related medical devices, its ability to regulate the industry is seemingly unmatched by the speed of scientific discovery and development. The continued research on stem cells and their potential therapeutic impact on patient care has pushed the boundaries of FDA regulation and has raised questions about the FDAs ability to keep up with science.

Arteriocyte, a clinical stage biotechnology company that develops novel stem cell products and medical devices, recently announced that it signed a Cooperative Research and Development Agreement (CRADA) with the United States Army Institute of Surgical Research (USAISR). The three-year CRADA, entitled “The Use of Concentrated Bone Marrow Aspirate from a Point-of-Care Device in Orthopaedic Trauma,” aims to investigate new stem cell-based therapies for orthopedic and battlefield-related injuries. Together, Arteriocyte and the USAISR will explore stem cell-based therapies for amputation prevention, burn debridement and post-surgical wound infection prevention.

The CRADA is designed to use Arteriocytes Magellan MAR01 system and NANEX technology. The FDA issued 510(k) clearance for Magellan, a bed-side medical device intended to rapidly produce platelet rich plasma from blood and bone marrow. The resulting tissue is rich in platelets and hematopoietic stem cells (HSCs), and can be applied to surgical cites to aid with tissue repair. The FDA has also approved the Magellan for a Phase I clinical trial of peripheral vascular disease, the obstruction of major arteries than can lead to ischemia of the limbs. NANEX technology is a biofunctional nanofiber-based 3-D scaffold that is designed to mimic the bone marrow environment. This technology is intended to rapidly produce HSCs. Arteriocyte is in the process of actively developing the NANEX technology for use in treatment of ischemic disease, identification and treatment of cancers of the blood system and rapid, high volume production of “universal-donor” red blood cells.

Researchers at the University of California, San Diego (UCSD) and the University of Massachusetts recently announced that they may have discovered the genetic mechanism and signaling pathway that controls the production of hematopoietic stem cells (HSCs). The research team believes finding the mechanism involved in creating cells during embryonic development is the next step toward creating blood stem cells for patient treatment.

The research study, which was published in Nature International Weekly Journal of Science, focused on a family of genes called Wnts, which have been identified as important to the process of embryogenesis. Researchers specifically isolated the Wnt16 gene and concentrated on examining its effect on production of HSCs. When researchers “turned on” Wnt16 in a population of zebrafish, whose blood is extremely similar to that of mammals, the expression of two types of ligands were triggered. Ten hours after fertilization, HSC production appeared in the zebrafish embryos. When Wnt16 was “turned off,” HSC production in the zebrafish was nonexistent. As a result, researchers believe Wnt16 is responsible for controlling a novel regulatory network for HSC production.

Researchers at UCSD and the University of Massachusetts are optimistic that continued research in the area of HSC production can have important implications for the development of blood stem cells and, eventually, stem cell-based therapies for blood disorders. This discovery adds to existing knowledge about HSC formation and the ways in which these types of cells communicate throughout the formative stages of blood cell production. “Were on the cusp of understanding something that people have been wondering about for decades,” said Wilson K. Clements, first author of the study and a postdoctoral fellow in UCSDs lab.

In spite of these new developments in the area of stem cell research and the scientific communitys prognostications about the therapeutic or curative potential of these stem cells, the FDA has only approved a few stem cell-based treatments, as we previously reported here and here. Even though the FDA has been cautious in outlining specific regulations for this burgeoning area of science, the continued research efforts to explore the mechanisms and value of stem cells may push the FDA to make difficult and more responsive decisions about its role in regulating this industry. Fuerst Ittleman will continue to monitor the progress and development of the FDAs regulation of HSC research and other stem cell-related devices and technologies. For more information, contact us at contact@fidjlaw.com.

Two Dietary Supplement Companies Found Guilty of Criminal Contempt for Violating Consent Decree

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A New Jersey jury found two dietary supplement companies guilty of several counts of criminal contempt for violating a consent decree, see Department of Justice announcement. A consent decree is an agreement wherein the defendant agrees to take voluntary action to remedy nonconformance and, in turn, settles a pending civil suit with the government. Criminal contempt generally refers to conduct that defies or disrespects the court and impedes the administration of justice.

Dr. Mohamed Desoky is the owner of two dietary supplement companies, Quality Formulation Laboratories, Inc. and American Sports Nutrition, Inc. These companies manufactured and distributed food products and supplements, including protein powder mixes and other dietary supplements, under the American Sports Nutrition brand and other private labels across the United States.

In December 2008 and January 2009, the U.S. Food and Drug Administration (FDA) launched an investigation of Desoky and his companies in Paterson, New Jersey. During the course of that investigation, the FDA observed several instances of noncompliance with good manufacturing principles (GMPs), see FDA Inspection Form here.

Based on the results of the FDAs investigation, the Justice Department filed suit against Desoky and his companies. In the complaint, the Justice Department claimed that Desokys companies produced adulterated food because its operations failed to meet the FDAs regulations for GMPs and that its insanitary conditions may have resulted in products contaminated with filth. The complaint also alleged that Desokys companies caused misbranding of food because their product labels failed to indicate the presence of a major allergen, milk.

The complaint alleged that upon observation of the production area, the FDAs investigator found raw ingredient bags with rodent urine stains and numerous holes where rodents had gnawed completely through the packaging. Furthermore, the investigator allegedly surveyed that at least two dead rodents”one of which was apparently cut in half”were found in production or product storage areas. The complaint went on to allege observation of multiple instances of live, active rodents and the existence of rodent excrement throughout the factory. The companys alleged “failure to have adequate control over their manufacturing process, sanitizing and cleaning operations, and employee training” may have resulted in a product containing a major allergen due to “cross-contamination” or “cross-contact” during the manufacturing process.

In March 2010, Desoky signed and entered into a consent decree of permanent injunction that required the defendants to immediately cease all manufacturing operations, including directly or indirectly receiving, manufacturing, preparing, packing, labeling, and distributing any article of food, including dietary supplements, see FDAs announcement of consent decree here. Pursuant to this consent decree, Desoky and his companies were prohibited from reopening their operations in New Jersey or elsewhere without first correcting their violations and obtaining FDA approval.

Soon thereafter, the FDA conducted another investigation of the Quality Formulations facility and found evidence that some manufacturing and distribution had occurred after the consent decree came into effect. Additionally, the FDA determined that Desoky transported some employees and equipment to a new facility to continue manufacturing and shipping products. As a result of this violation, the government filed criminal contempt charges against Desoky, his companies and Desokys two sons, who, even with the knowledge of the consent decrees terms, allegedly helped Desoky set up the new manufacturing facility in Congers, New York. Criminal charges were filed in the U.S. District Court for the District of New Jersey and the jury returned a guilty verdict. Sentencing has been scheduled by the court for September 7, 2011.

The jurys guilty verdict may be a strong indication to food and dietary supplement manufacturers of the importance of compliance with food safety laws. This case raises interesting questions about the role of consent decrees in future litigation with the FDA, as well as the FDAs future regulation of dietary supplement companies and GMPs. Fuerst Ittleman will continue to monitor the progress of these issues. For more information, contact us at contact@fidjlaw.com.

FDA Sued for Rescission of Menaflex’s 510(k) Clearance

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A medical device manufacturer brought suit against the U.S. Food and Drug Administration (FDA) last week for rescinding the devices 510(k) clearance and reclassifying the device from a Class II device to a Class III device. The FDAs decision forced the manufacturer to undergo additional and more burdensome application processes, and significantly impacted the manufacturers ability to market the device in the United States. Class II devices are subject to 510(k) premarket notification review, whereby the FDA must determine whether a device is at least as safe and effective, that is, “substantially equivalent,” to a legally marketed device that is not subject to premarket approval, see 21 CFR 807. Class III devices, on the other hand, are subject to premarket approval (PMA), which is based on the determination that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s), see 21 CFR 814. PMA approval is the most stringent type of device marketing application required by the FDA and must be obtained before a Class III device can be marketed in the United States.

In 2008, the FDA classified the Menaflex, a collagen-based surgical mesh implant intended to reinforce damaged meniscal soft tissue, as a Class II device under the Food, Drug, and Cosmetic Act (FDCA). At that time the FDA found Menaflex to be substantially equivalent to surgical mesh, a legally marketed predicate device. On March 30, 2011, the FDA rescinded this 510(k) clearance and reclassified Menaflex as a Class III device. ReGen Biologics, the manufacturer of Menaflex (or the Collagen Meniscus Implant, the name under which the device is distributed outside of the United States), filed for bankruptcy one month later.

Last month, ReGen filed a petition with the U.S. Court of Appeals for the District of Columbia Circuit seeking review of the FDAs rescission of the Menaflexs 510(k) clearance. Pursuant to the Administrative Procedure Act, ReGen also filed suit in the U.S. District Court for the District of Columbia for declaratory and injunctive relief last week. In its complaint, ReGen claims that the FDCA does not grant the FDA authority to rescind a 510(k) clearance, and seeks an order setting aside the March 30, 2011 rescission letter “as arbitrary, capricious, an abuse of discretion and not in accordance with law, and in excess of statutory jurisdiction, authority and limitations.”

According to the complaint, the review of Menaflexs 510(k) clearance was allegedly prompted by a letter from three members of Congress who urged Dr. Joshua M. Sharfstein, the Principal Deputy Commissioner and Acting Commissioner of the FDA at that time, to look into Menaflexs substantial equivalence determination. The FDAs decision to grant 510(k) clearance was allegedly influenced by outside political pressures from lobbyists and politicians.

In September 2009, the FDA released a preliminary report, which revealed that “multiple departures from processes, procedures, and practices occurred.” Furthermore, the failure of important decision-makers to sufficiently explain and document the bases for their decisions in an administrative record constituted “a clear deviation from the principles of integrity used in this review” and also “undermine[d] the ability of the agency to counter the suggestion that lobbying on behalf of ReGen affected the decision.” The report also concluded that a “focused scientific reevaluation of the decision to clear the [Menaflex] device is warranted,” but it did not specifically provide evidence that the device was unsafe or ineffective. ReGen alleges that this report created a pretense to justify re-review of the devices Class II status.

ReGen claims that the FDA lacks explicit authority under FDCA to rescind 510(k) clearances. In 2001, the FDA issued a proposed rule that would authorize the FDA to reconsider and rescind a 510(k) clearance, but it did not finalize that rule. Although the FDA does have authority to reclassify a device from Class II to Class III, see Section 513(e) of the FDCA, or to withdraw premarket approval of devices, see Section 515(e) of the FDCA, the decision to rescind Menaflexs 510(k) clearance was not expressly authorized under either of those provisions. The FDA did not provide a statutory or regulatory basis for its decision and has not yet responded to ReGens complaint. It remains unclear whether the FDA has implicit authority under FDCA to rescind 510(k) clearances.

This decision raises interesting issues involving the FDAs regulation of medical devices, the Administrative Procedure Act, and legal principles of ripeness, exhaustion, and subject-matter jurisdiction. Fuerst Ittleman will continue to monitor the progress of these issues in this case. For more information, contact us at contact@fidjlaw.com.

Improving the FDA Seafood Oversight Program

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On April 14, 2011, the U.S. Government Accountability Office (GAO) reported that the U.S. Food and Drug Administrations (FDA) seafood oversight program, which ensures the safety of all imported seafood, is “limited” and needs improvement. In response to the GAO report, Congresswoman Rosa DeLauro (D-CT) announced her support for increased funding and better oversight for seafood to protect the public. DeLauro demanded that we “ensure that the FDA has the additional resources needed to be successful at their mission in ensuring the safety of these products and the protection of the American public.”

Currently, 80 percent of all seafood consumed in the U.S. is imported, and half of all imported seafood is farm-raised. However, due to the high rates of infection associated with raising fish in farms, farmers find it necessary to treat their fish with drugs, such as antibiotics and antifungal agents, which creates a potential risk of drug residue for consumers.

Concerned with the safety and increasing quantities of imported seafood, DeLauro emphasized that “only one in every ten imported fish, shellfish, shrimp, or other seafood is tested for drug residues when it enters our country.” The FDA tests for residue of 16 unapproved drugs, in comparison to the European Union (EU) which tests for residue of as many as 50 drugs. The GAO recommended that the FDA should study the feasibility of adopting other practices, such as developing a national residues monitoring plan to control the use of aquaculture drugs to ensure the safety of imported seafood.

The GAO also found that sampling of imported seafood was inadequate. The FDA collects approximately 0.1 percent of imports for sampling, a very limited number. The EU samples as much as 4 percent of seafood imports. The GAO proposed that the FDA develop a more comprehensive import sampling program effectively using its laboratory resources. Currently, the FDA only utilizes 7 of 13 available laboratories for seafood drug residue testing. Additionally, the GAO found that the FDA should take into account the imported seafood sampling programs of other entities and countries.

The GAO further discussed that FDA inspectors do not typically visit foreign aquaculture farms to evaluate drug use or the capabilities, competence, and quality control of laboratories that analyze the seafood. In China, the FDA has only inspected 1.5 percent of seafood processing facilities in the last 6 years. The GAO noted that the FDAs assessment is limited by the lack of procedures, criteria, and standards. In contrast, the EUs inspection includes a review of the government structure, food safety legislation, and the foreign countrys own inspection program. The GAO recommended developing a strategic approach with specific time frames to enhance the current inspection program.

Fuerst Ittleman will continue to monitor the FDA for implementation of changes to the seafood oversight program. For more information, contact us at contact@fidjlaw.com.

FDA and Medical Devices Subject of Congressional Hearing

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The House Oversight & Government Reform Subcommittee on Health Care is scheduled to hold its “Pathways to FDA Medical Device Approval: Is there a Better Way?” hearing tomorrow, June 2, 2011. The panel is set to call FDAs Dr. Jeffrey Shuren, Director of Centers for Devices and Radiological Health; in order to “study the FDAs inconsistent application of reasonable standards for safety and effectiveness in approving medical devices, and the impact it has on American job creators.”

In addition to Shuren, the committee is set to call Congressman Erik Paulsen (R-Minn.), Jack Lasersohn of the venture capital firm The Vertical Group, Dr. David Gollaher of the California Healthcare Institute, and Dr. Rita Redberg, Director of Womens Cardiovascular Services in the Division of Cardiology at the University of California, San Francisco. Representative Paulsen is a supporter of the medical device industry and is currently pushing for legislation to “modernize” the FDA and block implementation of a $20 billion tax on medical devices. According to Paulsen, “[w]ere going to propose legislation that modernizes the FDA so that this industry remains strong. Companies dont mind if [FDA review] is rigorous. They want to make sure its relevant.”

Fuerst Ittleman recognizes the importance of a consistent pathway for FDA medical device clearance. We will monitor this and future hearings related to the FDA and changes to the medical device review process. For more information on FDAs regulatory oversight of medical devices, please contact us at contact@fidjlaw.com.

FDA Still Has Not Defined Gluten-Free After 3 Years

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In January of 2007 the U.S. Food and Drug Administration (FDA) proposed a definition for the term “gluten-free,” and three years later there is still no regulation regarding the term. Regulations for gluten-free labeling would help those who suffer from celiac disease, a chronic inflammatory disorder of the small intestine which is triggered by certain proteins known as gluten. Approximately 1 percent of the population suffers from celiac disease. Glutens are naturally present in certain cereal grains and form when wheat flour is mixed with liquid and kneaded. Grains that contain gluten are wheat, rye, barley, cross-bred hybrids, and possibly oats.

Currently, a label with the term “gluten-free” must be truthful and not misleading; however, there is no set definition provided by the FDA. The FDA has proposed that a food which bears the label “gluten-free” must not have more than 20 parts per million or more of gluten, which is the amount that can be reliably detected. The use of the label would be voluntary, meaning foods that are naturally gluten-free, such as milk or water, would not have to bear the label. Foods that would be prohibited from bearing the label are those which include barely, common wheat, rye, spelt, kamut, triticale, farina, vital gluten, semolina, and malt vinegar. Other countries such as Canada, Brazil and the Codex Alimentarius Commission, an joint international FAO/WHO standards organization, have defined gluten-free as having no more than 20 parts per million of gluten present.

Recently, the owner of Great Specialty Products in North Carolina was sentenced to 11 years in prison after he was found guilty of purchasing regular bread and rolls and repackaging them as gluten-free. Dozens of people complained of illness after consuming the goods.

Hopefully, the FDA will not take as long to define the term “gluten-free” as it took the U.S. Department of Agriculture (USDA) did to define the term “organic.” CNN reported in 1997, seven years after the Organic Foods Production Act of 1990, that USDA officials had finally drafted a set definition for organic.

On May 4, 2011, activists seeking to pressure the FDA to define gluten-free brought a 13-foot-tall gluten-free cake to Capitol Hill. In the absence of a federal standard, it is buyer beware.

Fuerst Ittleman will continue to monitor the FDA for changes to gluten-free labeling requirements. For more information, contact us at contact@fidjlaw.com.

All Induced Pluripotent Stem Cells (iPSC) Are Not Created Equal

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A recent study shows that the ability of nerve cells derived from human induced pluripotent stem cells (iPSCs) to function in the body may vary according to the method used to generate the iPSCs from adult stem cells. As we previously reported, iPSCs are adult stem cells that have been genetically reprogrammed to have the pluripotency character of embryonic stem cells. In the current study, a team based in the Republic of Korea and the United States has found that neurons and neural precursor cells (NPCs) demonstrated residual expression of exogenous reprogramming genes, early senescence, and apoptotic cell death when derived from virally reprogrammed iPSCs. However, NPCs and dopamine neurons were highly expandable and exhibited gene expression and other properties similar to those of the brains own dopamine neurons when derived from iPSCs generated using a protein reprogramming technique. These NPCs and dopamine neurons also restored motor deficits in rats with Parkinson disease.

According to the authors of the study, “[o]ur results suggest that protein-based reprogramming may be a viable approach for generating a patient-specific source of cells for treatment of [Parkinson disease] and other degenerative diseases.” We will continue to monitor the progress that scientists are making with induced pluripotent stem cells and other stem cells. For more information contact us at contact@fidjlaw.com

FDA Extends Comment Period for the Proposed Rule on Nutritional Labeling on Menus

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The U.S. Food and Drug Administration (FDA) is extending the comment period until July 5, 2011 for the proposed requirements for providing nutritional information on menus at chain restaurants and similar retail food establishments. As we previously blogged, the comment period for the proposed rule for chain restaurant menu labeling was set to expire on June 6, 2011. As we previously blogged (here, here, here, and here), the proposed rule involves a provision of the Patient Protection and Affordable Care Act (“PPACA”), the 2010 Healthcare Reform Law, which requires that chain restaurants and similar retail food establishments that are part of a chain with 20 or more locations doing business under the same name and offering the same menu items, provide calorie information directly on the menu and have nutritional information available upon request.

The FDA stated in todays Federal Register Notice that it has received several requests to extend the comment period. The additional time is needed, according to the requesters, for a number of reasons, “including a need for time to assess the effect of the proposal on the industry; a desire to conduct consumer research to support comments on the proposal; and the complexities of the proposed rule.”

For more information regarding labeling of food products and how the PPACA will impact your business, please contact us at contact@fidjlaw.com.

Drug Company Immunity A Possibility In North Carolina

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The North Carolina legislature is currently considering a bill that would provide immunity from lawsuits for drug companies in cases where the drug product in question had received FDA approval. If passed, North Carolina would be only the second state to provide such immunity for drug manufacturers. Michigan, which passed a similar law in 2005, was the first state to do so.

Prior to bringing a drug to market, drug manufacturers must receive FDA approval. During this approval process, the burden of establishing the safety and effectiveness of a drug is on the drug manufacturer. Traditionally, even after a drug has been approved for use, the law, both state tort law as well as federal regulatory law through the FDCA, has placed a continuing duty upon drug companies to warn its consumers of any potentially harmful effects of its products. Recent Supreme Court precedent has echoed this principle.

In Wyeth v. Levine, 129 S Ct 1187 (2009), the issue of whether FDA approval of a drug product was intended to preempt and prohibit contemporaneous state tort lawsuits was addressed by the United States Supreme Court. In Wyeth, the plaintiff filed tort action for negligence and strict product liability against a drug manufacturer in Vermont State Court alleging that the drug company had failed to include an adequate warning label describing the possible injuries which could occur from the injection of its drug product. In response, the drug manufacturer argued that the Plaintiffs failure-to-warn claims were preempted by federal law because: 1) it had received FDA approval for its products drug label; and 2) any state-law duty to provide stronger warnings would obstruct the purposes of the FDCA and federal drug labeling regulations because it would substitute a lay jurys decision about drug labeling for the expert judgment of the FDA.

In rejecting the drug manufacturers argument, the Court found that the FDCAs purpose was to bolster consumer protection and that Congress did not provide for federal remedies for consumers harmed by unsafe/ineffective drugs because state common law rights of action were already available. Further, unlike medical devices, Congress did not specifically provide for preemption of claims for drugs. Therefore, the Court found that “Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.”

However, if passed, HB 542 would provide immunity to drug manufacturers and sellers from product liability suits related to any drug sold or manufactured which first received FDA approval prior to production and sale. The only exceptions under the proposed bill are for cases where FDA approval was obtained through fraud or bribery. Such a law will have dramatic effects not only on the ability of consumers to hold drug companies accountable for selling dangerous or defective drugs but also on the State government itself bringing related claims.

An example of the likely effects of such legislation can be seen in a recent decision of the Michigan Court of Appeals interpreting a similar immunity statute under Michigan law. In Michigan v. Merck & Co. Inc., the Michigan Court of Appeals held that where the drug in question was approved by the FDA, the states suit to recover Medicaid money premised on fraud by the drug company in its representations regarding the safety and efficacy of the drug was barred under Michigan law. In that case, the court found that, though the suit was based on the Michigan Medicaid False Claims Act, the underlying allegations of the Complaint qualified the suit as a “product liability action” under Michigan law. As such, because 1) the States suit constituted a “product liability action” under Michigan law, 2) Mercks drug received FDA approval, and 3) that approval was not obtained through fraud or bribery, Merck qualified for immunity and the Court of Appeals remanded the case with orders to dismiss.

For more information regarding the drug approval process or for any questions regarding how your company can maintain FDA regulatory compliance, please contact us at contact@fidjlaw.com.