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.

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.

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.

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.

As part of its campaign to facilitate research on drugs and medical products, the Food and Drug Administration (FDA) recently issued new policies to encourage sponsors to conduct more informative and less costly early clinical trials. A new guidance on exploratory investigational drug applications (INDs) explains how scientists in industry and academia may test very small doses of a candidate compound to detect any pharmacologic effect before investing in more extensive in vitro and animal studies required for conventional phase 1 trials. The goal is to quickly identify products that show some promise of efficacy, and to halt research on those that fail to hit preliminary targets.

The Senate confirmed Lester Crawford in July as the official head of the Food and Drug Administration (FDA). Crawford's nomination had been put on hold as various legislators pressured FDA to approve an over-the-counter version of the "morning-after" pill, Plan B, and to support broader drug importing. Senate Finance Committee chairman Charles Grassley (R-IA) reflected broader concerns about FDA in criticizing Crawford for not tackling drug safety failures and FDA's "structural, personnel, cultural, and scientific problems." In the end, Grassley and most members of the Senate agreed that FDA would be better off with a permanent chief than without but failed to give the new commissioner unanimous approval. Crawford faces a rough road ahead as Congress and consumers continue to closely scrutinize FDA activities and initiatives.

Compliance in the pharmaceutical industry used to be virtually synonymous with compliance with the US Food and Drug Administration current good manufacturing practices (CGMPs), which date to the late 1970s. Once a manufacturer validated its processes and systems, it discouraged any changes that would require a time-consuming and expensive revalidation process. Manufacturing productivity, innovation, and product quality often fell victim to this approach.

When a firm embarks upon a contract manufacturing relationship with a third party, the questions that inevitably arise are: “Who is ultimately responsible for compliance? And what happens if and when a non-compliant situation arises?” The worst thing that can happen is to confront this question after a non-compliant situation occurs. A firm needs to know, from the beginning, who is responsible for each regulatory component.

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. Pharmaceutical and biopharmaceutical enterprises continue to face complex regulations and increased scrutiny from regulatory agencies related to the safety and efficacy of their products—from discovery and license approval through o­ngoing supply to the consuming public. These complexities and increased scrutiny can result in large fines and production shutdowns, making “top floor” executives more concerned with day-to-day “shop floor” operations. Although the initial push to focus o­n production control activities follows o­n the heels of unsettling events, many pharmaceutical and biopharmaceutical manufacturing executives are discovering that information systems are the key to providing reduced costs and increased competitiveness in the face of increasing regulatory pressure.

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The rules for electronic records and signatures still remain in effect. The change means that companies must now justify their decisions o­n whether or not to implement specific electronic controls with documented risk assessments and considerations of the record requirements detailed in the corresponding predicate rule.

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Rising healthcare costs and the pressure to expand medical coverage focus public attention o­n medicine outlays.

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