Funding Needed to Make Food Safety a Reality

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Now that the Food Safety Modernization Act has been signed into law, lawmakers face the added challenge of funding the efforts that will make food safety reform a reality. This funding is critical, as the Act has shifted the focus of the FDA from one of reaction to prevention.

Previously, the laws and strategy administered by the Agency primarily focused on the ability to swiftly respond to outbreaks by limiting the ability of contaminated food to reach consumers once cases of food borne illness were identified. This strategy allowed the FDA to focus its limited resources on enforcement and limiting the spread of contamination, rather than preventing these cases in the first instance.

As we previously reported, the Food Safety Modernization Act includes a number of provisions that will change the way the FDA approaches food safety measures. This will include increased inspections and mandatory recall authority. However, with all of this added power and the shift in focus from reaction to prevention, Congress has yet to provide increased funding for the measures. Lawmakers will likely take on this challenge in 2011, and these funding efforts will be critical for the goals of food safety reform to be realized.

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

FDA Seeks to Rid the Market of Unapproved Cough, Cold, and Allergy Drugs

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On January, 7, 2011, the U.S. Food and Drug Administration (FDA) published a notice in the Federal Register, informing companies of its efforts to step up enforcement on unapproved cold and cough drugs. The targets of these enforcement efforts are unapproved drugs being marketed for the treatment of cough, cold, and allergies. Previously exempted from certain market approval requirements under the Drug Efficacy Study Implementation (DESI) program, these products are considered new drugs by the FDA.

When the Food Drug and Cosmetic Act (FD&C Act) was enacted, new drugs required approval before they could be legally marketed and sold. Generally, the FD&C Act requires new drugs to be approved for safety, which may be established by the submission of a new drug application (NDA), unless otherwise eligible for an over the counter (OTC) monograph. However, because of their similarities to approved prescription drugs and OTC drugs, several unapproved drugs were temporarily exempted from this process through the DESI program. Under this program, the FDA allowed these products to be marketed and sold until final DESI determinations were made.

With the recent notice published by the FDA, the Agency has announced changes that will affect all orally administered DESI cough, cold, or allergy drugs. First, the FDA announced that any interstate shipment of products with outstanding hearing requests that were withdrawn is now unlawful. Second, the FDA announced that it will consider any pending hearing requests withdrawn, unless companies specifically respond with the intention of pursuing their request. While the FDA specifically names certain firms in the notice, the enforcement efforts also apply to products that are identical, related, or similar (IRS) to those in the DESI program. Additionally, the Agency warns that no further notice will be given prior to commencing enforcement actions.

While this recent roundup of unapproved new drugs signals heightened enforcement by the FDA, these efforts are decades in the making. As illustrated in the Notice, the hearings for most of these drugs had either been withdrawn or pending since the 1980s. While we previously reported the FDAs intentions to step up enforcement in 2011, this recent action shows that the Agency is ready to clear out old matters, one industry at a time.

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

USDA Issues Draft Guidance Concerning Organic Labeling

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The USDA recently announced the issuance of its draft guidance regarding the use of the term “organic” in food labeling. The draft guidance specifically addresses two issues in regards to labeling: the requisite organic ingredients for “made with organic” labeling, and the use of statements advertising the percentage of organic ingredients in final products.

First, the draft guidance details the different categories of organic products and the importance of this distinction in labeling. Under the USDAs National Organic Program (NOP), there are different levels of organic products, with the distinguishing factor being product composition. For instance, products that fall within the “made with organic” category must contain at least 70 percent certified organic ingredients. While a product that has 70 percent certified organic ingredients may be labeled as “made with organic,” the labeling cannot state “100% organic” or simply “organic” because it does not meet the requirements for this category.

In addition to explaining the applicability of the various terms and phrases for organic products, the USDA discussed the use of percentage statements in labeling. According to the draft guidance, a percentage statement, claiming a certain amount of specified organic ingredients, may not be made without the “made with organic” statement on products within this category. For instance, a product that is made with 70 percent certified organic fruit, thus qualifying for the “made with organic” category, may be labeled as being “made with 70 percent organic fruit.” While this percentage statement could not be used without the phrase “made with organic fruit,” the guidance points out that the “made with” statement could be made without reference to percentage, as this will not mislead consumers into believing that the product qualifies for the “organic” category.

With the issuance of this draft, the USDA is seeking comments regarding these issues to help refine its final guidance on this topic. Although only two main issues were specifically addressed by this document, the popularity of organic products and concerns regarding the accuracy of labeling by consumers and manufacturers will likely produce some interesting feedback for the USDA.

For more information about food labeling or USDA and FDA regulatory compliance, please contact us at contact@fidjlaw.com.

Advocacy Groups Push for “Humane” Labeling

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Recently, animal welfare advocates have been calling for the labeling of “humane” food.  On December 30, 2010, animal rights groups increased their efforts by updating their petition with the U.S. Department of Agriculture Food Safety Inspection Service (FSIS) and calling for rulemaking to standardize labeling requirements of eggs.  Specifically, the petition urges the USDA to standardize labeling requirements to alert consumers of the conditions under which food products have been produced.  Currently, a few major retailers, like Whole Foods, have signaled their support by announcing their intentions to inform interested consumers by adding signs indicating humanely-produced products in stores.

While there is no official word from the USDA regarding standardizing “humane” labels on eggs and other foods, this is not the only issue raised by consumer groups in regards to labeling.  The term “natural” has also come under scrutiny by consumer groups, as food companies are using this word to market their products to appeal to health-conscious consumers.  As we previously reported, a recent poll revealed that the majority of consumers were skeptical of the term “natural” being used on food labels and would like to see some uniformity regarding how “natural” is defined.  Similar to the use of “humane,” there is currently no standardized definition or certification process regarding the use of “natural” in labeling.  On the other hand, there is currently a certification process concerning the use of “organic” in labeling, which may only be used after several requirements are met.  Advocacy groups are calling for similar requirements to limit the use of “humane” and “cage-free” on food labels to those products that meet these kind of standards.

For more information about food labeling or USDA and FDA regulatory compliance, please contact us at contact@fidjlaw.com.

FDA Clears Aldagen to Test Stem Cell Treatment for Strokes

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Aldagen, Inc. announced yesterday that the FDA has cleared its investigational new drug (IND) application, allowing the biopharmaceutical company to proceed with phase II clinical trials. The focus of the clinical trials will be on the development of a stem cell therapy for treatment of stroke patients.

Currently, treatments for stroke sufferers are limited and largely restricted to the use of anti-coagulants. While these anti-coagulants must be administered within hours of a stroke, the stem cell therapy that Aldagen is developing is administered approximately two weeks after the patient has suffered a stroke. Because the therapy will lengthen the time for which treatment options are available to patients, the stem cell therapy may provide care to a greater patient population than traditional drug products could serve.

Earlier this week, we reported the FDAs clearance of another stem cell trial. With this newest IND clearance, it appears that stem cell treatment options are finally making headway with the FDA.
For more information on the FDA regulatory framework regarding stem cells or the Investigational New Drug process, please contact us at contact@fidjlaw.com.

FDA Clears the Way for New Embryonic Stem Cell Trial

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In what may be a sign that the FDA is loosening its grip on human embryonic stem cell (hESC) research, Advanced Cell Technology (ACT) announced that it has been cleared by the FDA to begin a new round of human clinical trials. The clinical trial will focus on developing a method to treat dry age-related macular degeneration, a condition that largely afflicts people over the age of sixty. According to ACT, previous trials using the therapy on animals have proven promising, showing “. . . a remarkable improvement in visual performance over untreated animals, without any adverse effects.”

With this recent FDA clearance, ACT is now the only company to have multiple hESC trials cleared by the FDA. As we previously reported, the FDA cleared the companys Investigational New Drug (IND) application in November, allowing ACT to begin a related clinical trial to treat a type of juvenile vision loss. In addition to these recently-cleared INDs, the FDA has cleared just one other hESC trial to date. In January 2009, Geron announced that the FDA had given initial clearance to allow the Company to proceed with clinical trials to treat patients with acute spinal cord injuries. While there are currently only three approved hESC clinical trials, these recent clearances may be an indication that the FDA is opening the door for further human embryonic stem cell research.

For more information on the FDA regulatory framework regarding stem cells or the Investigational New Drug process, please contact us at contact@fidjlaw.com.

Investments to Medical Device Firms Hindered by FDA

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Good news for U.S. companies, venture capitalists are optimistic about 2011. A national survey (found here) released by the National Venture Capital Association and Dow Jones VentureSource involving more than 330 venture capitalists showed a growing enthusiasm for investments, but not necessarily in medical device firms. According to the survey, the top three areas of growth were consumer Internet and digital media, cloud computing, and health care information technology. Biofuels and bioenergy are also expected to gain in investments this year. In contrast, medical device firms are not seeing as much money because, first, these other companies can be spun out for less venture capital than medical devices, and second, investors are cautious about investing in medical device firms because the inordinate delays associated with FDAs review of devices. The FDAs protracted timeline for review has created an uncertainty for when devices will reach the market. This uncertainty for an exit strategy may mean less venture capital for medical devices.

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.

New British Bribery law will mean trouble for American pharmaceutical firms

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A new British anti-bribery law taking effect in April, in certain ways more stringent than the Foreign Corrupt Practices Act (“FCPA”) in the United States, is worrying American drug companies enough begin  strengthening existing compliance programs in anticipation of the new law.

In recent years, the U.S. Department of Justice has exacted severe monetary penalties against pharmaceutical companies for violating the FCPA, which prohibits U.S. companies from engaging in bribery of foreign government officials. A recent Wall Street Journal article found here reported that, not surprisingly, British officials may specifically target pharmaceutical companies for enforcement of this new law once it is in effect. The new law is known simply as “The Bribery Act”.  

The Bribery Act prohibits any company operating in the United Kingdom, whether foreign or domestic, from making any illicit payments to foreign government officials. However, unlike the U.S. FCPA, The Bribery Act also prohibits illicit payments to private citizens or businesses, and even applies if the person making the payment does not even realize he or she is paying a bribe.

Notably, the Bribery Act does not include a crucial exemption included in the FCPA: Facilitation payments, or “grease” payments, permissible under the FCPA under certain circumstances, are not allowed under The Bribery Act.  As such, conduct which may be perfectly legal for an American pharmaceutical company based in Britain under the FCPA, may be illegal under The Bribery Act.

A stringent compliance regime, along with an understanding of both the FCPA and The Bribery Act is necessary for a company engaged in international business to avoid the traps and pitfalls both these laws can erect to harm its business. Our firm is experienced in conducting internal investigations to ferret out potential problems and to suggest policies and procedures to steer clear of violations.

Latest developments in the Pharma lawyer obstruction of justice case

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We had earlier blogged on the indictment of Lauren Stevens, the former Vice-President and Associate General Counsel for GlaxoSmithKline for allegedly making false statements and obstruction of justice in regard to a FDA investigation. That earlier blog is here. Now, in a recent development, it turns out that the government is seeking to prevent Stevens from relying on an “advice of counsel” defense at trial.

In a press account, it was suggested by her counsel that Stevens may raise an “advice of counsel” defense as it stated that Stevens did everything “consistent with ethical lawyering and the advice provided her by a nationally prominent law firm retained by her employer”. Soon afterward, the government filed a motion with the court to forbid Stevens from raising an “advice of counsel” defense at trial.

In that motion, which can be found here, the government states that “advice of counsel” cannot be a defense to the obstruction of justice charge against Stevens pursuant to 18 U.S.C. Sec. 1519 because it is not a “specific intent” crime. A “specific intent” crime is one in which the government must prove the defendant acted willfully, i.e., knew that the conduct charged violated the law. The government maintains in its motion that Sec. 1519 is a “general” intent crime, in that ignorance of the law is not an excuse; all that is required is proof that the defendant acted knowingly, i.e., not by mistake, when she allegedly covered up off label uses of a drug, with the intent to impede, obstruct or influence the FDAs investigation. According to the government, since Sec. 1519 does not require willful conduct, i.e., conduct committed with knowledge that it violated the law, advice of counsel that the conduct is lawful is irrelevant.

However, Stevens was also charged with other certain “specific intent” crimes that do require proof of willful conduct. 18 U.S.C. Sec. 1512, another obstruction of justice statute, requires proof that a defendant acted “corruptly”. 18 U.S.C. Sec. 1001, making false statements to the government, requires proof that the defendant knew he/she was acting unlawfully. In regard to these charges, the government argues in its motion that the “advice of counsel” defense should not be available until Stevens can satisfy that she fully disclosed all facts to the companys attorneys before seeking advice, and that she relied on the advice in a good faith belief that the conduct was legal. In another twist, the government takes the position that even if advice was given by lawyers to Stevens that her conduct was legal, those lawyers represented GlaxoSmithKline, not Stevens personally. Since she was not the lawyers client, according to the government, the defense should not be available.

What can so far be gleaned from the events in the Stevens case is how important it is to adequately document, in writing, the information provided to regulatory counsel and the advice received from regulatory counsel. In addition, in house counsel and compliance personnel must exercise heightened diligence to ensure that information provided to the FDA is accurate and complete. Given the governments hard nosed enforcement efforts, adequate documentation of this diligence and information and advice shared may make all the difference.

As of the date of this blog, Stevens had not yet responded to the governments motion. A hearing will most likely be held prior to a decision.

Produce Recalled After Testing Positive for Salmonella

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An outbreak of salmonella has led to a second recall of produce this week. Yesterday, representatives from J&D Produce, Inc. announced that it was recalling its cilantro and parsley after samples of the products tested positive for salmonella. Although there have been no reported illnesses associated with the consumption of these products, the Texas-based distributor announced its efforts were a “precautionary, voluntary recall.”

Although J&Ds recall is a voluntary measure, there is currently no federal authority to issue a mandatory recall of contaminated food products. Under the current regulatory scheme, the U.S. Food and Drug Administration (FDA) cannot force companies to recall contaminated products. Rather, most of the Agencys power in this area is in the form of publicizing news of possible contamination to the public. For instance, in the other recall situation that happened this week, the FDA issued a press release warning consumers not to eat Tiny Greens alfalfa sprouts because they may contain salmonella.

While exposing potential food hazards to the public is currently the FDAs main recourse in the area of recalls, this will soon change. As previously reported, the Food Safety Modernization Act, which is expected to be signed into law by President Obama within the week, will give the FDA more power in the area of food safety. Specifically, the Act provides the FDA with mandatory recall authority, enabling the Agency to issue a recall after a company fails to voluntarily recall a potentially hazardous product.

For more information about FDAs recall authority, please contact us at contact@fidjlaw.com.