Regulatory Articles

NO ONE REALLY KNOWS WHAT A DOCTOR IS thinking most of the time, and those of us who are patients can be happy about that. We are comforted when physicians keep their counsel until they complete an examination.

But that physician's poker face is no help to exhibitors who meet doctors at medical conferences. On the outside, they smile and shake hands, but the thoughts and feelings they withhold can tell a very different story.

A focus group convened by Impact Unlimited, an events, exhibits, and meetings company in Dayton, NJ, sought to understand doctors' attitudes toward conferences, exhibit halls, and pharma companies. Thirty high-prescribing doctors participated in the study, including radiologists, oncologists, neurologists, cardiologists, and primary care physicians, all of whom attended at least one national convention in their medical specialty in the last two years.

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.

With millions of impoverished people suffering from AIDS, tuberculosis, malaria, and a host of deadly conditions, biopharmaceutical companies face unprecedented demand for safe and effective treatments for third-world diseases. US, European, and international organizations are pledging billions to curb global epidemics, including the President's Emergency Plan for AIDS Relief (PEPFAR), which plans to spend $15 billion over five years to treat two million individuals with AIDS.

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.

A small but rising number of deaths from avian flu in Asia is prompting health experts to predict a global flu pandemic in the next few years. The World Health Organization (WHO) warns that the avian flu virus is likely to mutate and spread to humans, which could potentially kill millions worldwide and stress health care systems, as well as the international capacity to produce needed vaccines and medicines.

At home, the Department of Health and Human Services (HHS) is developing a Pandemic Influenza Preparedness and Response Plan, issued in draft form last August. Members of Congress now want a final plan and evidence of progress in developing vaccines and treatments to cope with a major flu pandemic. Coming in the wake of last year's devastating flu vaccine shortage, plus regular supply problems with routine children's vaccines, policymakers are very nervous about how the nation will deal with a global health crisis.

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.

A regulatory compliance review is a program designed to find discrepancies in registered filings, correct them, and identify the underlying systemic failures that caused noncompliance. This type of review differs from a good manufacturing practices (GMP) audit (see Figure 1) in that it compares the filing with master process records (e.g., master batch records, quality standards) instead of comparing actual files with master production documents. In general, discrepancies between a master production record and the actual practice in a factory or laboratory is considered a GMP compliance issue.

Figure 1: A regulatory compliance review differs from a good manufacturing practices audit in that it compares the filing with master process records (e.g., master batch records, quality standards).

A regulatory compliance review is beneficial in many situations:

by Joy A Cavagnaro, President, Access BIO, USA & President, Regulatory Affairs Professional Society, USA and Cynthia Rosso, VP Communications, Regulatory Affairs Professional Society, USA

In both o­ncology and cardiology, new EU rules correct some errors but leave others overlooked. Progress marches o­n-and with it the regulatory framework. A new guideline should emerge from the European Medicines Agency by the end of this year to revise European Union guidelines o­n anticancer medicine evaluation in man.1 The revision will remedy an obsolete focus mainly o­n conventional cytotoxic compounds.

View Full Article

There are six mechanisms for bringing a veterinary biologic into use when circumstances demand a rapid response and full licensure will take too long.

View Full Article