Regulatory Articles

Democrats are back on top in the Congress and are mapping a broad agenda for change. Prescription drug pricing, medical product safety, and access to treatments are high on the priority list. Manufacturers will be on the hot seat answering questions about patent policies, high-risk products, and why new biotech therapies cost so much. However, the real challenge will be gaining approval of a bill to reauthorize the Prescription Drug User Fee Act (PDUFA) before the program expires on September 30, 2007. Such legislation would renew user fees for medical devices and continue the pediatric drug exclusivity program.

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How much do regulatory agencies know about nanotechnology or microfluidics? Yesterday, the answer was probably, "not much." Tomorrow, it may be "a lot." The reason is that new technologies push the agencies to expand their expertise.

Let's think about how the coyote alters the appearance of the hare over millennia. The coyote's pursuit of the hare changes the abilities of the hare by selecting for hares that escape capture. As the hares become faster or more stealthy, the coyotes must adapt to continue their pursuit. This changes the form and function of both entities.

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Whether to thwart illicit activities or improve compliance reporting, pharmaceutical sales operations must have confidence in the paper-based and electronic signatures they gather from physicians while in the field. The need to manage signature capture, especially in the pharmaceutical industry, is not a new challenge. FDA 21 CFR Part 11 guides the industry on this topic, as it relates to electronic signature capture. Since confirming orders or authorizing receipt of drug samples necessitates a physician's signature, the ability to authenticate a signature is the key variable in these compliance-centric processes.

With today's clinical investigators awash in regulatory burdens, it's high time sponsors provided a lifeboat.
According to clinical investigators, it's ugly out there! Investigators and site staff consistently report that managing site operations is difficult—particularly maintaining positive cash flow and profitability. Lead generation has intensified as competition for new study grants has increased. Study protocols have become more complicated and demanding. Patient recruitment and retention challenges have escalated. And the burden of regulatory compliance has become onerous and extremely frustrating.

Indeed, in recent interviews with clinical investigators, regulatory compliance is one of the top burdens that sites face today. Many argue that compliance requirements place unreasonable demands on study staff time and focus, and may, ultimately, undermine study conduct performance.

Peter O'Donnell, the View from Brussels columnist for Applied Clinical Trials, is a freelance journalist who specializes in European health affairs. He is based in Brussels, Belgium.

This was the first full year of the European Union's revised medicines legislation, which came into force late in 2005. New legal provisions gave the European Medicines Agency in London responsibility for evaluating generic and biosimilar medicines, "compassionate use" medicines, medicines for use outside the EU, and "core dossier" applications for pandemic-influenza vaccines. All new medicines for HIV/Aids, cancer, diabetes, neurodegenerative disorders, and "orphan" diseases now have to be submitted through the centralized authorization procedure.

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Any regular commentary on the environment for the pharmaceutical industry in Europe is bound to have a predominantly negative tone, so it is a welcome change to be able to record a positive development in the regulatory context—and one that should make life a little easier for everyone involved in developing new medicines.

Starting July 1st, the European Medicines Agency is changing the way it provides scientific advice on the research and development of new medicines, including assistance on protocols. Sponsors can expect final advice after as little as 40 days, and certainly within 70 days—compared to the previous 100-day procedure. The experts will be involved earlier and more systematically. The agency's Scientific Advice Working Party is being expanded from 22 to 26 members.

Government regulators have never watched pharma sales forces as closely as they do today. On top of familiar reporting requirements, such as how many samples were given to whom, federal regulators want to know what marketers were thinking. Why, they sometimes want to know, did a sales rep give one physician more samples than another one down the hall? If they want more specifics, they can even ask for a rep's call notes. And while the reps are keeping up with federal laws, they have to learn a new set of regulations for every state in their territory. In some states, for example, nurse practitioners can sign sample receipts, but in others, doctors must sign personally for their samples.

The pharmaceutical industry imposes higher standards on advertising, PR, and medical education agencies than any other industry, except perhaps the financial services sector. Agencies need to keep up with constantly changing rules for advertising and promoting drugs or devices.

Pharmaceutical companies are hyper-focused on compliance. They cannot afford the high costs of noncompliance, which can include criminal prosecution, corporate integrity agreements, negative media attention, loss of business, and damage to product reputation—not to mention high legal fees and penalties. In the past five years, pharma paid well over $3 billion in government fines. Yet even as regulatory compliance becomes a greater priority for pharmaceutical companies, communications agencies fail to understand the urgency of the issues.

Peter O'Donnell .Applied Clinical Trials, Dec 1, 2005 .
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From a historical perspective and subsequent to the political changes in Central and Eastern Europe, the G-7 summit held in Paris in mid-July 1989 established a special instrument of financial support for Poland and Hungary to Assist Restructuring their Economies1 (PHARE) and later extended it to cover other European countries in transition. The PHARE program was one of the three pre-accession instruments financed by the European Union (EU) to assist the applicant countries of Central and Eastern Europe in their preparations for joining the EU.

In view of the EU enlargement in 2004, which was going to increase the number of member states from 15 to 25, there was a need to prepare the candidate countries so that legislation and practices related to medicinal products would be equivalent in all member states and in the European Economic Area (EEA) countries Norway, Iceland, and Liechtenstein, since these three countries follow the EU regulatory framework for medicinal products.