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FDA

FDA Guidance for Clinical Research Projects Using Expansion Cohorts in First-In-Human Clinical Trials to Expedite the Development of Oncology Drugs and Biologics

In early August 2018, the Food and Drug Administration (“FDA”) announced the availability for guidance in Clinical Research projects relating to expansion cohorts used in first-in-human (“FIH”) clinical trials that are used to expedite the development of Oncology Drugs and Biologics. The guidance is directed towards clinical sponsors in their design and conduct of FIH clinical trials intended to expedite the development of cancer drugs, including biological products that use multiple expansion cohort study designs. These studies typically employ multiple, concurrently accruing, patient cohorts, which use individual cohorts that assess the different aspects of the safety, pharmacokinetics, and antitumor activity of the drug. The FDA provides guidance for (1) the characteristics of drug product best suited for consideration for development under a multiple cohort study; (2) information to include in investigational new drug application submissions to justify the design of multiple expansion cohorts; (3) when to interact with FDA on planning and conduct of multiple expansion cohort studies; and (4) safeguards to protect patients enrolled in FIH expansion cohort studies.

FDA Faces Forward with Flexible Genetic Guidance

In recent years, the FDA has examined a record number of revolutionary medical devices, many of which have been genetic tests. Genetics has taken the world by storm. The medical world continues to look toward genetics as a promising next step in revolutionizing treatment, while the American public has shown a growing interest in learning more about themselves through services like Ancestry and 23andMe. In an effort to gain a foothold on the rapidly developing field of technology, the FDA has recently made efforts to modernize its approach by issuing new guidance to ensure the validity of these tests.

The Food Safety Modernization Act is Just the Beginning of the FDA Compliance We’ve Been Waiting For

Despite the United States having one of the safest food supplies in the world, more than 48 million Americans get sick from foodborne illnesses and diseases each year, and more than 128,000 are hospitalized and 3,000 die from similar issues that are largely preventable. On January 04, 2011 President Obama signed the Food Safety Modernization Act (“FSMA”) into law. This enactment was called the “most sweeping reform” of U.S. Food Safety laws in more than seventy years. But seven years later, the act is still only partially enforced as the FDA has faced resistance from the government as well as a lack of funding. The FMSA was and is intended to enable the FDA to protect the health of the public by strengthening the food system in the United States. While change and reform in the industry are necessary, what good are new reforms if they will not be enforced for years to come?

How Would a New Bipartisan Bill that Encourages the DEA to Increase Opioid Quotas Affect Drug Manufacturer Efforts to Remain Compliant?

After years in an opioid crisis, the United States now faces an opioid epidemic that has left the government and public desperate for relief and a workable solution. A group of senators hopes to be part of the solution with the introduction of a bipartisan bill that aims to better enable the DEA to establish opioid quotas. Despite already-present struggles to effectively manage its quota system and policies, the DEA would be given significantly more responsibility under this bill. Drug manufacturers, directly responsible for following DEA, FDA, and OIG regulations to hopefully resolve the epidemic, will need to grow their compliance efforts and create responsive solutions to remain both profitable and compliant.

What Does a Federal Government Shutdown Mean for Compliance?

For the first time since 2013, on Saturday, January 20th, 2018, the U.S. government ran out of money when Congress failed to pass a spending bill to fund the federal government. Much of the federal government’s operations have ground to a halt due to the lack of funding. Because Congress is seemingly at an impasse over immigration policy, the shutdown may last several days, if not weeks. In light of Loyola’s upcoming symposium exploring what happens when regulation is not enforced, it is interesting to consider how, in a similar vein, the shutdown affects compliance.

The Hazards of an Unregulated Cosmetics Industry

The cosmetics industry, unknown to many, is essentially not regulated by a federal regulatory agency. Cosmetics technically fall under the purview of the Food and Drug Administration (“FDA”), but there are few requirements that manufacturers must comply with. The FDA only requires that manufacturers comply with several labeling regulations so companies can avoid listing a product’s total ingredients, and the FDA does not require manufacturers to report health complaints. The FDA instead relies on direct reports of adverse events from consumers, which has the potential to delay remedying a potentially dangerous situation. A study published in JAMA Internal Medicine found that between 2015 and 2016, the number of complaints of adverse health results related to cosmetic products more than doubled from the previous years. Additionally, the FDA only has the equivalent of six full-time inspectors to monitor three million shipments of cosmetics that come into the United States each year. Last year, inspectors only conducted tests on about 364 of those shipments, and 20 % of those shipment that were inspected led to adverse findings.

Medical Marijuana and Maintaining FDA Compliance

Regardless of opinions on legalization, many people accept the idea that medical marijuana, and more specifically CBD, can be a powerful treatment for many medical conditions. However, there has been one major roadblock: the FDA. According to the FDA, more than 90 warning letters over the past 10 years have been released to companies claiming that their cannabis products cure various symptoms. The most common is the claim that marijuana prevents or treats cancer. In 2017, as the medical properties of marijuana continue to be trumpeted to the general public, the FDA is still working to protect the public by issuing warning letters to marijuana providers making unsubstantiated claims.

Powdered Caffeine – Friend or Foe?

Most Americans consume caffeine regularly. High amounts of caffeine are found in a wide range of drinks including sodas, coffee, and energy drinks. Like most things, caffeine is safe for most people as long as it is consumed in moderation. The dosage size of powdered caffeine has come under scrutiny mostly due to its potency. The Food and Drug Administration has notified powdered caffeine distributors that their products are potentially dangerous to consumers as they have the possibility of causing serious adverse health consequences, including death. The FDA’s notices required powdered caffeine distributors to accurately label and market their products ensuring they are in compliance with the law. Four of the five distributors removed their products from the market following the notices, and the fifth distributor no longer markets to consumers.

FDA Nutrition Facts Label: Will the New Administration Approve a Change?

On May 20, 2016 the Food and Drug Administration (FDA) announced a new nutrition facts label for packaged foods, the first significant makeover in twenty years. The new label reflects new scientific information regarding our diets; such as the link between diet and chronic diseases like obesity and heart disease. This new label comes after three years of negotiations and proposed improvements between the FDA, scientists, and lobbying groups. Those in favor of the changes have pointed out that the old nutrition fact labels had no information to help consumers determine if they were complying with the U.S. Dietary Guidelines’ recommendations and that the labels did not reflect the necessary nutrients per day. These changes affect manufacturers as well as consumers. Manufacturers are not only worried about having to reformulate their foods, but also having to reconsider their ability to make certain nutrient content claims in advertisements and on packaging. Companies will also have to consider additional costs associated with packaging design, development of new artwork, regulatory consultation and review to ensure label compliance, reconsideration of inconsistent advertising, and human costs associated with potential new operating procedures and training to ensure compliance with the new regulations. In response to complaints from manufacturers, consumer advocates are reminding the White House Administration to remember that the FDA’s mission is protect the health of the American people not the bottom line of manufacturers.

Compliance Spotlight: Dominique Vittori, Abbott Laboratories

Dominique Vittori is a Regulatory Affairs Associate for Abbott Laboratories working within Abbott Diagnostics Division. Abbott Laboratories is a worldwide healthcare company that is most known for pharmaceutical development but eventually branched out to include medical devices, nutritional products and research-based drugs/pharmaceuticals. Ms. Vittori earned her Bachelor’s degree from the University of Illinois, where she majored Molecular and Cellular Biology. Ms. Vittori sought a career in compliance because of the opportunity to put her background and expertise in the sciences to use in a corporate setting, and has been most rewarded by the ability to see the tangible results of her work at Abbott Labs.

The following is an interview with Ms. Vittori where she gives an inside look into her daily life as a compliance professional.