Drug companies face two regulatory reviews when adopting new trade names for their drug products in the United States, at the United States Food and Drug Administration (“FDA”) and the United States Trademark Office (“USTO”). Both of these agencies review trade names to reduce or eliminate any confusion that the name might cause. However, because the agencies are trying to protect different classes of people from confusion, their review standards and procedures often differ. FDA is trying to prevent healthcare professionals from giving the wrong medicine to a patient, while the USTO is trying to prevent companies from adopting names that confuse consumers regarding the source of the labeled goods.
Corruption and Bribery Concerns Affecting Japanese Pharmaceutical Companies Operating in the United States
Recent criminal enforcement actions against Japanese companies and executives have made very clear that no company or employee is safe from charges of bribery and corruption. Japanese pharmaceutical companies that operate in the United States must be aware of anti-corruption laws in both the United States and Japan. These laws can be used to prosecute misconduct occurring in Japan, the United States, and even other countries—highlighting the need for companies to ensure that they have robust compliance policies and programs in place around the globe.
“Health care delivery for the aging population, already a problem, will become an even greater concern in the future,” said Yuji Matsue, Senior Vice President, Eisai Company Ltd., and Chairman & CEO, Eisai Inc., at the 25th Annual General Assembly of New York Pharma Forum. “By 2050 the age 85 and older population will increase by 350 percent. The number with Alzheimer’s Disease (AD) is also projected to increase more than three-fold.” AD is the most expensive health condition in the United States, he added, now costing society $214 billion a year and projected to cost $1.2 trillion by 2050. The program took place on December 5th at the New York Athletic Club in New York City and featured four other speakers in addition to Mr. Matsue, the panel facilitator:
Antitrust accusations based on so-called “product hopping” continue to make the headlines, most recently after the Attorney General for the State of New York (the “AG”) brought an antitrust lawsuit against Actavis, PLC and its subsidiary Forest Laboratories, LLC (collectively “Forest”) based on their marketing plans for Alzheimer’s drug Namenda®. “Product hopping” is a term used by the United States Federal Trade Commission (“FTC”) to refer to the practice by some pharmaceutical companies of withdrawing one version of a drug in favor of another, as generic competition for the first version approaches.
I don’t have to tell the readers of this blog that a lot of very significant changes have occurred in both the Japanese drug industry and Big Pharma companies over the last 25 years, since the founding of New York Pharma Forum (NYPF). Not surprisingly, these changes have had an effect on the organization.
Many Japanese drug industry executives were adamant 25 years ago that mergers were a Western phenomenon and would not affect the Japanese industry. “It is not the Japanese way of doing business,” we heard. I recall a meeting of New York Pharma Forum in the early ‘90s at which the guest speaker was a Ministry of Health & Welfare official from Tokyo, who told the audience not to expect the government to protect Japanese pharma companies any longer from global competition in the domestic Japanese market. He predicted that, in order to survive, there would be many mergers in the Japanese pharma industry, which, he said, was sorely in need of consolidation. A blanket of silence descended on the room.
Twenty-five years ago I participated in an intense series of meetings in New York with a group of Japanese pharmaceutical executives and one Japanese government official. We were planning the launch of a new industry organization, which we named New York Pharma Forum.
On June 6, 2014, the Food and Drug Administration (“FDA”) issued a response granting the two pending FDA citizen petitions filed by members of the Medical Information Working Group (“MIWG”), an ad hoc coalition of drug and device manufacturers to which Ropes & Gray LLP serves as one of the outside counsel. This response reflects the agency’s on-going effort to clarify its regulatory approach regarding manufacturer communication of scientific and medical information to health care professionals (“HCPs”). This post summarizes the key aspects and implications of that response.
Topics: FDA guidance
On June 6, 2014, the Food and Drug Administration (“FDA”) issued a draft guidance on new risk information for approved drugs. The document is entitled “Guidance for Industry: Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices.” This post summarizes the key aspects of that document.
Topics: FDA guidance
By Amit Dhawan, MD, and Michael Fronstin, Kantar Health
Pain is a large and growing market globally, affecting more than 1 billion people worldwide. It is a high-prevalence, low-diagnosis market and often results in extremely high unmet needs. As anyone who experiences pain, either chronically or acutely, can tell you, it is incredibly difficult to treat because everybody experiences it differently, and the many different types of pain add another layer of complexity.
An ethnic group is defined as a group of people who identify with each other based on intrinsic factors, such as genetic similarities due to common ancestry, and extrinsic factors, such as shared cultural experiences or environment. Therefore, one’s ethnicity is a fundamental aspect of life that defines a person, and that differentiates that person from others.
Ethnic differences have become important in the field of clinical drug development because they may impact the absorption, distribution, metabolism, or excretion (ADME) of drugs, and may be relevant to an understanding of a drug’s efficacy and safety.