On October 17, 2011, the Seventh Circuit Court of Appeals affirmed a district court ruling dismissing a state law consumer fraud claim, finding that it was preempted by the Federal Food, Drug and Cosmetic Act (FD&C). The suit alleged that General Mills, Inc. and Kellogg Co. failed to disclose pertinent information concerning their “Fiber Plus” chewy bars.

In the district court case, the Plaintiff claimed that while the labeling of the product declared fiber to be 35% of the daily recommended value, this information was misleading to consumers. Because the fiber found in the product was allegedly a “non-natural,” processed fiber, providing fewer benefits than consumption of natural fiber, the Plaintiff argued that the manufacturers of Fiber Plus should have declared the origins of this fiber in labeling.

Found here, the Seventh Circuit’s Opinion discusses how state law labeling requirements may not exceed those found in the FD&C. In particular, 21 U.S.C. § 343-1(a)(5) provides that no state may establish “any requirement respecting any claim of the type described in section 403(r)(1) made in the label or labeling of food that is not identical to the requirement of section 403(r). . . .” 21 U.S.C. § 403(r) gives the U.S. Food and Drug Administration (FDA) authority to regulate nutrition labeling and related claims for food products. Taken together, these provisions prevent states from imposing and enforcing requirements that are additional to or different from those set forth by the FDA. In this case, 21 C.F.R. § 101.54(d), the FDA regulation pertaining to nutrient content claims for food, provides the requirements that manufacturers must comply with when making “fiber claims.” Reasoning that the regulation does not require a declaration of the origins of fiber in food labeling, the Seventh Circuit ultimately found the plaintiff’s state law claim preempted.

For more information regarding the labeling of food products, contact us at contact@fuerstlaw.com.

On October 14, 2011, Representative Brian Bilbray introduced a bill before the U.S. House of Representatives, entitled the “Novel Device Regulatory Relief Act of 2011.” The Bill, which seeks to amend the federal Food, Drug and Cosmetic Act (FDCA), focuses specifically on altering the way that medical devices are reviewed by the U.S. Food and Drug Administration (FDA).

Found here, the Bill focuses on changing the FDA’s de novo review process. The de novo process is currently a separate review pathway for medical devices, created to be particularly useful for manufacturers of lower risk devices that do not require formal FDA approval via the Premarket Approval (PMA) process. Differing from the 510(k) process, de novo review may currently only be initiated after a device has been issued a Not Substantially Equivalent (NSE) letter by the FDA. In short, this means that the only devices that may seek de novoreview are those that have not been cleared via the 510(k) process. The newly introduced legislation may revamp this underutilized pathway by allowing manufacturers to submit a request for de novo review “. . . without regard to whether such person has received written notice of classification into class III.”

While the de novo review process has not proven effective in practice and has been widely criticized for lack of transparency, the FDA has been working to change the process throughout 2011. As we previously reported, the FDA recently released its plans to streamline the de novo review process, publishing its draft guidance entitled “De Novo Classification Process (Evaluation of Automatic Class III Designation),” on September 30, 2011. However, as shown in the guidance, the FDA’s plans may not have proven as effective as industry had hoped. Where the FDA had planned to introduce a process whereby a pre de novo submission (PDS) would be submitted concurrently with a 510(k) petition, it is unclear how this would have resolved the issues confronting the de novo process. Because the statutory language of the FDCA only allows for initiation of de novo review upon the issuance of a NSE letter, this new legislation may actually result in increased utilization of the de novo review process.

Fuerst Ittleman has extensive experience successfully navigating medical devices through FDA review. For more information on FDA’s review of medical devices, please contact us at contact@fuerstlaw.com.

On October 14, 2011, Par Pharmaceutical, Inc. (Par Pharma) brought suit against the U.S. Food and Drug Administration (FDA) challenging the Agency’s rules that restrict claims made in marketing pharmaceutical products. Filed in the U.S. District Court in Washington D.C., the suit seeks a declaratory judgment and an injunction against the Agency’s enforcement of the speech restrictions. Found here, the Complaint alleges that FDA’s rules prevent Par Pharma from promoting its drug for both approved and unapproved uses.

Par Pharma’s drug, Megace ES, was approved by the FDA in 2005 for the treatment of anorexia and cachexia, an AIDS-related wasting syndrome. Since its approval, the drug has been prescribed by doctors to treat other, related disorders, a practice known as “off-label” use. However, the FDA prohibits companies from promoting drugs for off-label uses, and it regularly enforces against companies which do so. For instance, the pharmaceutical manufacturer Allergan has been targeted for utilizing off-label marketing in the past. For more information regarding the Allergan suit, see our previous report here.

The FDA’s jurisdiction to restrict off-label use is a contentious issue. While the FDA currently prohibits manufacturers from marketing FDA-regulated products for unapproved uses, the agency does not have the authority to prevent doctors from issuing prescriptions for off-label uses. Rather, the latter fits squarely within the practice of medicine, an area traditionally regulated by the states. Even where the FDA only attempts to restrict manufacturers without encroaching on the practice of medicine, FDA’s efforts relating to off-label use are often viewed as hindering innovation inasmuch as manufacturers and doctors are prevented from discussing new, alternative uses for FDA-approved drugs and devices.

Although Par Pharma challenges the FDA’s restrictions on off-label marketing, its suit also alleges that the Agency is unlawfully prohibiting the marketing of its drug for its approved uses. Specifically, Par Pharma claims that FDA is encroaching on its First Amendment rights by preventing the company from marketing its drug for its approved uses to physicians who are likely to prescribe the drug off-label. While this issue is slightly different than that regarding the promotion of off-label uses, it will be interesting to see who ultimately prevails.

For more information on FDA regulations and acceptable pharmaceutical marketing practices please contact us at contact@fuerstlaw.com.

On October 14, 2011, Medisca, Inc. pled guilty to introducing a misbranded drug into interstate commerce in violation of the federal Food, Drug and Cosmetic Act (FDCA). The Complaint, which was filed on October 14, alleged that Medisca purchased a drug called “Somatropin” from China and then proceeded to distribute the drug to various pharmacies throughout the United States.

The primary issue in the case was that Somatropin, a type of human growth hormone (HGH), was being marketed as having approval from the U.S. Food and Drug Administration (FDA). According to the Complaint, the drug was not FDA approved, rendering the drug’s labeling false and misleading and therefore misbranded under the FDCA. Although it was Medisca’s contention that it possessed a valid National Drug Code (NDC) pursuant to FDA’s rules requiring every manufacturer and/or distributer to register and list all drugs in commercial distribution, the FDA warned that a NDC does not denote a drug approval. Rather, in order for drugs to be properly distributed under the FDCA and accompanying FDA regulations, a New Drug Application (NDA) must be obtained for all new drugs prior to entering interstate commerce.

Additionally, only drugs that possess an NDA may be marketed as “FDA approved.” The Office of Prescription Drug Promotion (OPDP), formerly the Division of Drug Marketing, Advertising, and Communication (DDMAC), is a division within the FDA specifically tasked with overseeing promotional claims and labeling of drugs. OPDP ensures that marketing claims are within FDA regulations and limited to what the FDA has actually approved. Further, because drugs must possess a valid NDA before lawfully being advertised as “FDA approved,” the FDA flatly prohibits other types of products, like over-the-counter (OTC) drugs and medical devices with FDA clearance, from being marketed as approved by the FDA.

For more information regarding the FDA’s regulation of drugs and the requirements pertaining thereto contact us at contact@fuerstlaw.com.

An illustration of FDA’s increased powers, a recent seizure was the first directed by the FDA under the authorization of the Food Safety Modernization Act (FSMA). Specifically, on October 11, 2011, the U.S. Food and Drug Administration (FDA) announced that U.S. Marshals seized food products at the FDA’s request. The food, which was being held at a storage and processing facility in Washington, was originally detained due to an infestation found during a FDA inspection. After having ordered the detention of the food products on September 2, 2011, FDA sought a warrant for the arrest of the products in federal court, ultimately resulting in the seizure.

As we previously reported, the FSMA expanded FDA’s powers in a number of areas, including those dealing with the administrative detention of goods. While FDA formerly had the authority to order the detention of goods, the Agency had to possess “credible evidence or information indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals.” 21 C.F.R. § 1.378 (2011). Today, pursuant to the FSMA, the FDA may detain foods where there is “reason to believe” that the food is adulterated or misbranded.

On May 5, 2011, the FDA issued its interim final rule, relaxing the “credible evidence” standard to require only a “reasonable basis” to believe that food is either adulterated or misbranded, and thus marking an increased burden on industry as well as the Agency. First, because the FDA must only have a reasonable basis for believing that a food is adulterated or misbranded, industry must be increasingly-vigilant in ensuring that its products are at all times compliant with FDA regulations, including the minute particularities concerning the labeling of products. Additionally, this increased power – if fully enforced – could strain the FDA’s overburdened resources.  

Fuerst Ittleman will continue to monitor the FDA’s measures under the FSMA. For more information regarding the FSMA or FDA regulations, please contact us at contact@fuerstlaw.com or (305) 350-5690.

On October 7, 2011, the U.S. Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) announced the official launch of the parallel review program. An effort to increase patient access to a variety of medical devices and drugs, the program is designed to facilitate the development of innovative medical products and reduce the time between FDA approval and CMS national coverage determinations.

In September 2010, FDA and CMS announced their intentions to implement a pilot parallel review program for innovative medical devices, drugs, and biological products. Please see our previous report for more information regarding the announcement of the program. In response to the initial Federal Register Notice, the Agencies received 36 public comments regarding what products would be appropriate for parallel review, what procedures should be developed, and how a parallel review process should be implemented.

The Federal Register Notice announcing the implementation of the program details the procedures for the program’s voluntary participation and guidelines for the Agencies to follow during the review of a product. The program will not change the existing separate review standards for FDA product approval and CMS coverage determinations. However, parallel review may ultimately benefit patients by expediting the time involved with the review process, as the separate determinations will run concurrently. In order to qualify for the program, product candidates must meet one of the following criteria:

1. New technologies for which the sponsor/requester has a pre-investigational device exemption (IDE) or an approved IDE application designation;
2. New technologies that would require an original or supplemental application for premarket approval (PMA) or a petition for de novo review; or
3. New technologies that fall within the scope of a Part A or Part B Medicare benefit category and are not subject to a national coverage decision (NCD).

The FDA and CMS are currently accepting submissions for products seeking parallel review. The Agencies intend to perform parallel reviews for up to five products per year for the next two years, with the possibility for extension.

Fuerst Ittleman, PL will continue to monitor the progress of the FDA and CMS parallel review program. For more information on how FDA and CMS review medical products and how the parallel review process may be beneficial to your product, please contact us at contact@fuerstlaw.com.

On September 8, 2011, the U.S. Food and Drug Administration (FDA) announced that the comment period for its draft guidance, entitled Dietary Supplements: New Dietary Ingredient Notifications and Related Issues, will be extended until December 2, 2011. The draft guidance, issued on July 5, 2011, consists of more than 120 Q&As aimed at helping industry determine whether a dietary ingredient is a NDI, whether a notification is required, and what information should be included in the notification. Please see our previous report here for more information regarding NDIs.

Having been a controversial issue, various industry associations submitted requests for extension to the FDA, including the Natural Products Association (NPA), Council for Responsible Nutrition (CRN), United Natural Products Alliance (UNPA), American Herbal Products Association (AHPA), and Consumer Healthcare Products Association (CHPA). Additionally, the Alliance for Natural Health USA (ANH-USA) and other health advocacy groups claim that over 355,000 emails have been sent utilizing an online template to petition Congress regarding the draft guidance. Many activists view the draft guidance as a barrier to nutritional supplement access and claim the proposed regulations are beyond the scope of FDA authority. After receiving numerous requests to extend the comment period in order to provide a more comprehensive response, the FDA agreed to the extension.

Found here, the draft guidance is currently available for public comment. Fuerst Ittleman, PL will continue to monitor the progress of the draft guidance. For more information regarding the regulation of dietary supplements, please contact us at contact@fuerstlaw.com.

On September 19, 2011, the U.S. Food and Drug Administration (FDA) published its Guidance document entitled “Marketed Unapproved Drugs – Compliance Policy Guide.” Found here, the document details the widespread availability of unapproved drugs on the market and explains the Agency’s priorities with respect to enforcement. Because of the large volume of these drugs on the market and the FDA’s limited resources, the Agency is forced to prioritize how it will exercise its enforcement discretion. Setting forth its highest priorities, the FDA intends to continue targeting unapproved drugs that pose significant health risks to consumers.

However, the Agency notes that it will also focus its enforcement efforts on those companies marketing unapproved drugs that are reformulated in an effort to evade FDA enforcement. As discussed in the Guidance, the FDA will consider “the timing of the change, the addition of an ingredient without adequate scientific justification (see, for example, 21 CFR 300.50 and 330.10(a)(4)(iv)), the creation of a new combination that has not previously been marketed, and the claims made,” when deciding whether to bring an enforcement action against those marketing reformulated products. While there are often legitimate reasons for a manufacturer to reformulate its product, it remains to be seen how FDA will focus its enforcement actions on only those that are reformulated in an effort to evade FDA enforcement.

For more information on FDA enforcement measures or compliance, please contact us at contact@fuerstlaw.com.

On September 27, 2011, Del Monte Fresh Produce N.A., Inc. (Del Monte) voluntarily dismissed its suit against the U.S. Food and Drug Administration (FDA) which alleged that the Agency had no basis to suggest its cantaloupes were the source of a salmonella panama contamination. Found here, the Notice of Dismissal cites the lifting of the import alert that formed the basis of the suit as its reason for seeking dismissal. The Import Alert, which prevented cantaloupes from Guatemala from being imported into the United States, was lifted the same day.

As we previously reported, companies sometimes forced to challenge importation restrictions imposed by the FDA. In Del Monte’s case, the Company filed suit on August 22, 2011, and was able to obtain the relief it sought in only one month’s time. Similarly, we previously reported on the Seagate case, where we successfully challenged the FDA’s detention of Seagate’s shipments, and secured the release of the goods soon after bringing suit against the Agency. While companies are often reluctant to bring suit against the FDA, these cases show that litigation may be a company’s only means of successfully challenging unlawful regulation.

For more information on FDA enforcement measures or import compliance, please contact us at contact@fuerstlaw.com.

On September 30, 2011, the U.S. Food and Drug Administration (FDA) announced the release of its draft guidance, entitled “De Novo Classification Process (Evaluation of Automatic Class III Designation).” The Guidance comes as a part of the FDA’s overhaul of its medical device review scheme, as the FDA intends to implement to streamline the way medical devices are reviewed and cleared. As previously reported, the FDA announced its plans to overhaul its entire system for reviewing and clearing medical devices earlier in 2011 and highlighted its intentions to target the “de novo” review process as a means to lessen the burden for manufacturers, while continuing its mission of public safety.

Unlike the de novo review process, the 510(k) program requires a new device to demonstrate substantial equivalence to a previously cleared device in order to obtain clearance from the FDA. The de novo process is different, as it is a means to obtain clearance for medical devices that have no clear predicates. While the de novo process currently is only open to medical device manufacturers that have submitted a 510(k) and have received a “not substantially equivalent” (NSE) determination, the FDA proposes changes to this requirement in its draft guidance.

Found here, the Guidance discusses FDA’s additions to the de novo process, allowing for de novo petitions where no 510(k) has previously been submitted. The FDA proposes to institute a new pathway for de novo submissions initiated by a “pre de novo submission” (PDS). A PDS, the Agency explains, is a means for a submitter to show the FDA why its device would be suitable for the de novo process. If the FDA determines that the device would be appropriate for the de novo process, a suitability letter will be issued and the next step will be for the device sponsor to submit both a 510(k) and de novo petition concurrently with the FDA. Because the Agency would have already determined that the device is appropriate for de novo review, the idea is that the device sponsor will not have to wait for a NSE letter because the Agency will already have all the documentation it needs to clear the device through the de novo process.

While the FDA expresses optimism for the new additions to the de novo process, it remains to be seen whether the changes will bring the streamlined change that all have hoped for. Although FDA has attempted to simplify the de novo process, its proposed changes do little to combat key flaws, like the lack of transparency, that have caused so much criticism of the review of medical devices. The FDA has only published five of its de novo approval decisions to date, all of which have been published within the last year as part of FDA’s Transparency Initiative.

Further, it appears that the FDA’s new approach may actually complicate matters, as the Agency seeks to review two distinct submission types at once, the 510(k) and de novo petition. Because each of these submissions center largely on mutually excusive stances, with the 510(k) submission arguing that the device is substantially equivalent to a cleared device and the de novo petition asserting that the device has no clear predicates, it is unclear how the Agency will actually review the submissions.

The FDA’s review of medical devices through the PMA, 510(k), and de novo processes are complex. Fuerst Ittleman has extensive experience successfully navigating medical devices through FDA review. For more information on FDA’s review of medical devices, please contact us at contact@fuerstlaw.com.