New Bill Seeks to Limit the Way Manufacturers Handle Recalls

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Last week, United States Senator Charles Schumer (D-NY) introduced a bill aimed at limiting the options that manufacturers may pursue in the event of a product recall.  Found here, the Consumer Recall Protection Act states that “. . . a person may not sell to a consumer any covered product that is subject to a recall.”  As written, the Act will apply to a variety of products, including food, drugs, cosmetics and devices, all covered by the Food, Drug, and Cosmetic Act (FD&C).  If enacted, the Consumer Recall Protection Act will prohibit manufacturers from selling recalled products to consumers until the defect prompting the recall is remedied. 

The Bill may have come as a response to the recent controversies raised by Johnson & Johnson’s “phantom recall” efforts.  As previously reported, the handling of several recalls by J&J has led to scrutiny of the current recall process by the FDA and Congress.  After years of concern regarding the company’s manufacturing and responsiveness to FDA warnings, the massive recall of Children’s Tylenol in 2010 led Congress to probe the effectiveness of the FDA’s regulation of drug manufacturing.  During a recent hearing before the House, the FDA expressed its concern regarding J+J and the company’s efforts to postpone recalling its products.  In what is known as a “phantom recall,” J+J hired contractors to go into stores and purchase its products rather than conducting a widespread and highly-public voluntary recall.   

In addition to combating the “phantom recall,” recent legislative efforts have focused on reforming the current voluntary recall process for drug products.  Because the current drug recall scheme is voluntary, the FDA is often able to prompt manufacturers into initiating recalls after alerting the public of the possible dangers associated with the products at issue.  While the recent Food Safety Modernization Act, discussed here, granted authority to the FDA to issue mandatory recalls in certain circumstances, the FDA does not currently have the power to initiate recalls of drugs.  However, the voluntary recall process for drug products may soon come to an end.  As recently reported, new legislation has been introduced in the House that focuses on reforming the FDA’s ability to oversee and enforce drug safety.  The bill, known as the Drug Safety Modernization Act, largely mirrors the recent food safety legislation and contains provisions giving the FDA mandatory recall authority over drug products.  

While it appears that Congress is scrambling to restore public confidence in the FDA’s ability to keep consumers safe, the potential effectiveness of the newly proposed Consumer Recall Protection Act is questionable.  Although the bill may largely be a response to J+J’s phantom recall efforts, the Act will only prevent companies from selling products to consumers once a recall has already been initiated.  Because the Act would only apply once a recall has been initiated, it would not have prevented the phantom recall situation that J+J engaged in.

FDA to Unveil Rules for Reviewing Biosimilars “Very Soon”

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The U.S. Food and Drug Administration (FDA) will announce new rules for reviewing the first copies of biologic drugs, also known as “biosimilars.” According to FDA Commissioner Margaret Hamburg, these new rules will be formally implemented in “the very near-term time frame.”

The health-care overhaul passed last year included a provision that authorized the FDA to develop a process for approving cheaper copies of compounds made from living cells. The FDA is currently evaluating different models for evaluating that the biosimilars work as well as the products they copy.

In the absence of final rules, generic companies have been filing the same biologics license applications (“BLAs”) used for brand-name drugs. The BLA process does not create savings for patients like the generic drug program for traditional medicines. According to the Congressional Budget Office, it is estimated that Americans would save $25 billion in a decade through rules allowing copies of biologic drugs.

Hamburg stated that the FDA plans to discuss with industry in the next couple of months how much it will charge to review applications for biosimilar products under the new rules. This is a step in the right direction for moving forward with rules for reviewing biosimilars. Fuerst Ittleman will monitor FDAs progress with developing final rules.

For more information on biosimilar products, please contact us at contact@fidjlaw.com.

NOAA Seeks to Expand Aquaculture to Increase Consumption of Domestic Seafood

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The National Oceanic and Atmospheric Administration (NOAA) recently released a draft policy document detailing its intentions to increase aquaculture domestically. The cultivation of sea-life in selected environments, a process known as aquaculture, is a priority for the NOAA because of the current disparity between domestic and overseas seafood production. According to the draft policy, “[a]pproximately 84 percent of the seafood consumed in the United States is imported, about half of which is sourced from aquaculture.” Further, while half of seafood consumed in the U.S. comes from aquaculture, only about 5 percent comes from domestic sources. While the NOAA is seeking to increase the growth of aquaculture domestically, these efforts are being touted as a means to reduce the trade deficit. With approximately $9 billion worth of seafood being imported into the United States each year, seafood is one of the largest contributors to the deficit.

For more information about the policies or regulations affecting trade, please contact us at contact@fidjlaw.com.

Medical Device Manufacturers Seek Quick Approval Overseas

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Recently, medical device manufacturers have been shifting their operations overseas in an effort to speed up the approval process. More relaxed regulatory oversight abroad has led some of these companies to make the move to Europe, Asia, and Latin America. Rather than deal with the stringent approval process for medical devices in the United States, these companies are looking for a less costly and time consuming way to bring new products to market.

While the FDA is responsible for administering the regulatory scheme surrounding medical devices in the United States, critics argue that the Agency has gone too far by scrutinizing new products and creating a lengthy, complex process. Currently, the two main pathways for medical devices to enter the market are through premarket approval (PMA) and the 510(k) process. While the premarket approval process is a more complicated and time-consuming pathway, both require a device manufacturer to demonstrate that the product is safe and effective for its intended use. The advantage that device manufacturers may find abroad is a more relaxed approval process through which a demonstration of a devices safety alone may secure the approval necessary to bring a product to market. Unlike the regulatory requirements in the United States, showing that a device is effective for its intended use is often not required abroad.

However, this perceived advantage may be short-lived. The FDA has begun to review the current pathways for medical devices. As we previously reported, the FDA recently proposed several changes to the 510(k) process. These changes are primarily aimed as increasing the efficiency of the device approval process and reflect some recognition that reform is necessary to ensure that the United States remains at the forefront of medical device innovation. As we previously reported, the FDA has also proposed its Innovation Initiative, a plan targeted at streamlining the medical device approval process thereby reducing costs associated with research and development of new devices. While no official changes to either the PMA or 510(k) process have come into effect, the FDA expects to implement some of these measures later this year.

The FDAs review of medical devices through the 510(k) or PMA process is complex. Fuerst Ittleman has extensive experience successfully navigating medical devices through FDA review. For more information on FDAs review of medical devices, please contact us at contact@fidjlaw.com.

FDA Announces Availability of “Medical Device Innovation Initiative” Report for Public Comment

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The U.S. Food and Drug Administrations (FDA) announced in the Federal Register on February 9, 2011 that its report entitled “Medical Device Innovation Initiative” is available for public comment. This report proposes potential actions to be taken by the FDAs Center for Devices and Radiological Health (CDRH) to facility the development, assessment, and regulator review of innovative medical devices.

On February 8, 2011, the FDA proposed its “Innovation Pathway,” which is a priority review program for “new, breakthrough medical devices.” The agency announced that the first submission to the program will be a “brain-controlled, upper-extremity prosthetic.” The FDA is seeking further public comment before the Pathway will be used more broadly.

CDRH announced 25 actions it will take this year to improve its 510(k) program, the FDAs premarket review process for certain medical devices. CDRH has expressed its desire to “increase its use of emerging science to foster innovation and improve the predictability, consistency, and transparency of its decision making.” Click here to read the FDAs “510K) and Science Report Recommendations: Summary and Overview of Comments and Next Steps.”

The report on medical device innovation outlines CDRH actions that may be put into place to accelerate the agencys evaluation of innovative devices. Some of these actions include:

  • Facilitate the development and regulatory evaluation of innovative medical devices;
  • Strengthen the U.S. research infrastructure and promote high-quality regulatory science; and
  • Prepare for and respond to transformative innovative technologies and scientific breakthroughs.

The Federal Register notice announcing the availability of the report for public comment acknowledges that the U.S is the global leader in innovative medical devices. The notice states that millions of Americans benefit from innovative medical devices that “reduce suffering, treat previously untreatable conditions, extend lives, and improve public health.” CDRH has stated that because of the need for these innovative devices, the office has committed itself to assuring that these new technologies and products are available on a timely basis while still retaining their safety and efficacy.

The FDA has been criticized by the medical device industry for its 510(k) process. The industry has been vocal in its views that the review process is much too slow and much too inconsistent. Click here to read an article in the New York Times on domestic medical device firms sending business overseas.

CDRH is seeking public comment on the report and the proposals outlined therein. The FDA will be holding a public meeting to garner stakeholder feedback at its White Oak, Maryland campus on March 15, 2011.

The FDA news release on its Innovation Initiative can be found here.

FDA Releases Criteria For Criminal Prosecution Under Park Doctrine

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The FDA has released “criteria” it developed for consideration of which cases would be appropriate for misdemeanor criminal prosecution under the Park Doctrine, named after a Supreme Court case called United States v. Park, 421 U.S. 658 (1975).

Under the Park Doctrine, an executive may be criminally prosecuted for violations of the Food, Drug & Cosmetic Act, if he or she had, by reason of his or her position in the corporation, responsibility and authority either to prevent in the first instance, or to promptly correct the violation of the law. This is known as the “responsible corporate officer doctrine,” which does not require that the corporate officer be aware of wrongdoing within the company. Use of this doctrine is limited to misdemeanor offenses involving regulatory or public safety crimes that do not have an intent requirement.

The new criteria released by the FDA is not binding on the agency, and creates no rights or benefits on the behalf of a putative defendant who is potentially subject to Park responsible corporate officer liability. In addition to the individuals position in the company and whether he or she had the authority to prevent or correct the violation, the FDA will also consider, when determining whether to bring a Park Doctrine indictment:

  1. Whether the violation involves actual or potential harm to the public;
  2. Whether the violation is obvious;
  3. Whether the violation reflects a pattern of illegal behavior and/or failure to heed warnings;
  4. Whether the violation is widespread;
  5. Whether the violation is serious;
  6. The quality of the legal and factual support for the proposed prosecution; and
  7. Whether the proposed prosecution is a prudent use of agency resources.

The announcement regarding the new criteria may be found here.

The FDA has expressly stated that it will seek to increase the amount of Park Doctrine criminal prosecutions of corporate executives whose companies are involved in Food, Drug & Cosmetic Act violations. This increase in enforcement is part of the FDAs aggressive stance in a variety of investigations, one of which has recently resulted in the prosecution of a companys lawyer for obstruction of justice, as we previously blogged here. Compliance reviews, and if necessary, a strong defense team in the face of such potential jeopardy to ones liberty is advisable, necessary and prudent in todays regulatory environment. In addition, when facing a potential Park Doctrine prosecution, executives should consider obtaining separate counsel from their employers, free of any potential conflicts of interest with the company.

Fuerst Ittleman attorneys have represented clients in a variety of FDA-related criminal investigations and prosecutions. For more information, please contact us at contact@fidjlaw.com.

Fourth Circuit Dismisses Challenge To Federal Embryonic Stem Cell Research Funding Citing Lack Of Standing Of Challengers

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On January 21, 2011, the United States Court of Appeals for the Fourth Circuit affirmed a decision of the District Court of Maryland dismissing a consolidated case challenging the federal funding of research involving embryonic stem cells. In agreeing with the District Court, the Fourth Circuit found that both plaintiffs lacked standing, an essential constitutional requirement to bringing case before the court. A copy of the decision can be read in full at: Mary Scott Doe v. Obama.

Article III of the United States Constitution provides that the judicial power of the federal court system extends to “cases” and “controversies.” However, in order to bring a case, the plaintiff must have “standing” to assert its claim. To satisfy the constitutional requirement of “standing,” a plaintiff must establish: 1) it has suffered an “injury in fact” which is “concrete and particularized” and “actual or imminent” and not merely “hypothetical;” 2) causation, i.e. the injury is “fairly traceable to the challenged action of the defendant;” and 3) redressability, meaning that “it is likely, as opposed to merely speculative” that the injury will be remedied by a favorable decision. Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc., 528 U.S. 167, 180-81 (2000).

In Mary Scott Doe, two groups of plaintiffs attempted to challenge the constitutionality of Executive Order 13505 (“EO 13505”) and its implementing National Institute of Health (“NIH”) Guidelines which expanded federal funding of human embryonic stem cell research. NIH Guidelines currently permit funding for research involving stem cells from embryos “donated by individuals who sought reproductive treatment . . . and who gave voluntary written consent for the human embryos to be used for research purposes.” 74 Fed. Reg. 32170, 32174. The plaintiffs alleged that EO 13505 and the NIH Guidelines violated the 13th and 14th Amendments to the U.S. Constitution as well as the Administrative Procedure Act and the Dickey-Wicker Amendment, which prohibits use of federal funds for “research in which a human embryo . . . is destroyed, discarded, or knowingly subjected to risk of injury or death.”

The first named plaintiff, Mary Scott Doe, represented a class of all frozen embryos held throughout the US for either research or adoption purposes. The plaintiffs argued that the class of frozen embryos had standing because EO 13505 and the NIH Guidelines “increase the embryos risk of being reduced to . . . stem cells” thus creating an “injury in fact” necessary to bring a case. However, the Court rejected this argument, stating that in order to establish standing “named plaintiffs who represent a class must allege and show that they personally have been injured, not that injury has been suffered by other, unidentified members of the class to which they belong and which they purport to represent.” (emphasis added). The Court went on to state that because the “complaint provides no basis to conclude that the named plaintiff . . . [will] suffer any injury at all, much less an injury due to the challenge government policy,” “Doe” has failed to allege a “concrete and particularized harm.” Thus, the Court found that “Doe” could not establish an injury in fact.

Furthermore, the Court found that even if “Doe” could assert an injury, “Doe” could not establish causation on the part of the defendant, the US government. Here, the Court found that funding for research was limited to those embryos which were voluntarily donated for research by biological donors. As such, any injury which could have occurred was the result of the independent actions of a third party, not the named defendant. “Where a third party . . . makes the independent decision that causes an injury, that injury is not fairly traceable to the government . . . .The mere fact that the government permits private donors to chose to donate their embryos for research does not . . . make the decision fairly traceable to [EO] 13505 or the NIH Guidelines.”

The Fourth Circuit also affirmed the dismissal for lack of standing for the second group of plaintiffs, parents who have children that were adopted frozen embryos and who are considering adopting embryos again. The Court found that the adoptive parent plaintiffs did not claim that they had already suffered an injury. Rather, the adoptive parent plaintiffs claimed that they faced the treat of a future injury because “EO 13505 will reduce the number of in vitro human embryos available for adoption such that they will be unable to adopt.” However, the Court went on to find that the adoptive parent plaintiffs failed to allege facts to “infer that such injury would be actual or imminent.”

In finding that the adoptive parent plaintiffs lacked standing, the Fourth Circuit relied upon Supreme Court precedent established in Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992). In Lujan, the Supreme Court found that in order for a plaintiff to establish standing through the claiming of a future injury, it must be alleged that future injury is “certainly impending.” Id. at 565 n. 2 (emphasis in original). In this case, the Fourth Circuit found that “the plaintiff parents . . . did not allege that they have already tried and failed to adopt embryos, nor do they allege any concrete plans for future adoption, so the possibility that they will never suffer the alleged injury looms too large.”

Fuerst Ittleman has built a reputation not only in the field of complex litigation but also in the legal aspects of the cutting edge field of stem cell research. If you have any questions pertaining to new NIH guidelines or to contact a complex litigation attorney please contact Fuerst Ittleman PL at contact@fidjlaw.com. For more information on Fuerst Ittlemans experience in the legal aspects of stem cell therapies, age management medicine, food and drug law in general, and FDA regulatory and enforcement actions, please visit our Food, Drug and Cosmetic Law practice page.

GAO Suggests that FDA Shift Gears Regarding Health Claims in Food Labeling

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The GAO, an independent agency that investigates the efficacy of federal programs for Congress, recently issued a report recommending that the FDA reform the way it handles claims made in food labeling. This report comes as a result of a performance audit that the GAO conducted throughout 2010 where the FDAs oversight of qualified health claims and structure/function claims was evaluated.

While health claims are those that characterize the relationship between a food or food component and a health-related condition, “qualified health claims” have an added limitation. In a qualified health claim, the relationship between the consumption of a food and a health-related condition is limited by providing a statement in labeling that qualifies the amount of scientific support backing the claim. In contrast, structure/function claims are those that describe the relationship between a food or food component and its effect on a structure or function of the body.

The key issue that the FDA must consider regarding both of these types of claims is whether food manufacturers possess a level of scientific support to make these claims. The FDA is tasked with overseeing and enforcing federal food labeling requirements, which prohibits the use of false or misleading claims in food labeling. However, in the area of health-related claims, the FDA is not the only agency tasked with enforcing federal requirements. The Federal Trade Commission (FTC) is responsible for enforcing federal laws that prohibit deceptive acts and practices. The FTC shares jurisdiction with the FDA in the area of health-related claims, and where the FDA focuses mainly on food labeling, the FTCs focus is on food advertising.

Although the FDA also targets food manufacturers for making improper claims in advertising, a key distinction between the FDA and FTC is that the latter possesses subpoena power. While the FTC can require companies to turn over relevant evidence concerning the scientific support substantiating its claims, the FDA has no such power. This distinction is highlighted in the GAOs report and according to the GAO, may be a critical factor limiting the efficacy of the FDAs oversight of health-related claims in food labeling. Because of this limited ability to force companies to turn over documents in support of their claims, the GAO concluded its study with a recommendation that the FDA to seek guidance from Congress regarding what authority could be used to require companies to provide scientific evidence of health-related claims.

For more information regarding FDA and FTC regulatory compliance, please contact us at contact@fidjlaw.com.

Seafood Executives Plead Guilty to Selling Mislabeled Fish

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Shortly before a trial that was to begin in Mobile, Alabama, two executives from an Arizona based seafood wholesaler, Consolidated Seafood Enterprises, pled guilty to a scheme to defraud the public by mislabeling imported fish. The plea agreement of one of the defendants may be viewed here.

Consolidated Seafood Enterprises contracted with importers to bring in fish from overseas and then sell them to wholesalers that supplied restaurants and stores. Both executives admitted that they bought and sold approximately 385,000 pounds of frozen catfish, called basa, swai and sutchi, which was falsely labeled to evade customs duties. They then passed 101,000 pounds off as grouper to customers in southern states including Alabama and Florida. They sold 25,000 pounds of Lake Victoria Perch as grouper or snapper. The defendants also admitted to overstating the size of shrimp they sold and falsely labeling them as wild caught from the U.S., when in fact they were from shrimp farms in foreign countries.

Under the terms of the plea agreement, one executive Karen Blyth, will serve 2 years and 9 months in prison, while her co-defendant, David Phelps will serve 2 years in prison. The defendants also agreed to the forfeiture of over 7,000 pounds of fish. The Court will determine the amount of fine and both executives will not be able to hold ownership or managerial interests in the seafood industry until after they serve 3 years of supervised release after completing their prison sentences. The Court accepted the plea agreement on January 24, 2011.

The mislabeling of food products is a violation of the Food, Drug & Cosmetic Act, and the Lacey Act, while submitting false statements to Customs to evade duties is a violation of Title 18 of the Criminal Code. Fuerst Ittleman lawyers have substantial experience representing clients involved in both the distribution and importation of food products who are under federal criminal investigation for violations of these laws.

FDA Begins Overhaul of 510(k) Process

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This week, the FDA announced its plans to overhaul its system for reviewing and clearing medical devices. The plan, which contains 25 distinct actions that the FDA intends to implement in 2011, comes as a result of two internal working groups that were created by the FDAs Center for Devices and Radiological Health (CDRH) in 2009. The CDRH set up these groups in an effort to address widespread concerns regarding the FDAs premarket notification process.

Currently, the most utilized pathway for medical device manufacturers to gain FDA clearance necessary to market new devices is through the 510(k) process. This process requires submitters to provide highly-detailed information regarding the intended use of the device, including any safety issues posed and how the device compares to other devices that have already gained FDA approval or been cleared through this process. In what is known as “substantial equivalence,” the FDA issues a finding allowing new devices to come to market and is primarily based on the perceived link between the applicants submitted comparable devices and the applicant device. Conversely, if the FDA believes that the applicant device is not substantially equivalent to the comparable devices that were submitted, then the Agency will issue a determination of “NSE,” meaning that the device at issue is not substantially equivalent to a legally marketed device. A determination of NSE may be reached for a variety of reasons, including any perceived differences between the intended use of the comparable devices and the applicant device or added risks that bear on the devices safety. Because there have been ongoing concerns regarding the unpredictable and inefficient nature of the 510(k) process, including what truly leads the FDA to conclude a new device is not substantially equivalent, the FDA unveiled its plan to improve this process.

Aimed at increasing the efficiency of the 510(k) process, while ensuring that the safety of new devices on the market is not diminished, the FDA intends to take several actions in the coming year that may greatly impact the pathway for the approval of medical devices. For instance, the Agency plans to publish several draft guidance documents that are intended to create more transparency regarding FDA determinations. To this end, the FDA intends to provide guidance concerning when it believes clinical data should be submitted, what kinds of information supports “intended use,” and how comparable devices should be utilized in 510(k) submissions.

Additionally, the FDA intends to streamline its “de novo” review process, which may help lower-risk medical devices gain the clearance necessary to enter the market. This is particularly important for new devices that cannot point to clear comparable devices on the market but do not pose heightened risks to safety. The de novo process entails a review of a device submission after the Agency has made the initial determination that the device is not substantially equivalent to any currently being marketed. While de novo review has come under fire for being too complicated and time-consuming, the FDAs plan seeks to breathe new life into this underutilized process.

The FDAs review of medical devices through the 510(k) or PMA process is complex. Fuerst Ittleman has extensive experience successfully navigating medical devices through FDA review. For more information on FDAs review of medical devices, please contact us at contact@fidjlaw.com.