I’m here in Seattle at the USP Science and Standards Symposium, which is focusing on all things biologic and biotech. Representatives from a majority of the pharmacopeia’s expert panels are here, as are a few FDA officials, and industry members from around the world–some 30 countries are represented in fact. Various new approaches by USP are aiming to help industry better understand, develop, test, and manufacture biological products, including biosimilars. Read more »

Concern about pharmaceuticals in our water supply has been in the public consciousness for a few years now. In 2009, the Environmental Protection Agency found traces of various drugs in fish caught in rivers that receive effluent from wastewater-treatment plants. The drugs were believed to come from doses that people had excreted or flushed down the toilet. In response, FDA updated its guidelines for disposing of drugs. New research, however, shows another potential source of drugs in our waterways. Read more »

As I wrote last week, the market for vaccines is expanding, and the newswires have stories about these products almost daily. Sanofi and GlaxoSmithKline, to name just two major players, are increasing investments in research and manufacturing capacity for these therapies. Kalorama Information predicts that sales of pediatric vaccines will grow even more quickly than sales for adult vaccines. Yet drugmakers have surely noticed that not all publicity about vaccines has been positive. Read more »

The patent cliff is beginning to reduce Big Pharma’s sales figures as generic versions of branded drugs enter the market. Although FDA has remarked that pharmaceutical innovation is beginning to increase, not all companies are going to be able to market enough new drugs to make up for lost sales. So how will these vulnerable companies maintain their profits? Read more »

As Congress returns from summer recess, and national campaigns begin, job creation is undoubtedly the theme for the near term. Debates over the role of government in stimulating economic growth through fiscal and regulatory policy are inviting opinions from all sides of the political spectrum. Despite all the contention that is and will continue to ensue, there is generally one agreed-upon precept: innovation is a valuable tool to create and sustain economic growth. But how does the quest for innovation square with government regulation? That debate is taking shape not only broadly but in the nascent field of synthetic biology, where scientific, public-health, and business interests are converging. Read more »

During this cost-conscious time, many patients and other healthcare payors are opting for generic versions of branded pharmaceuticals. Biopharmaceuticals have claimed a place in the spotlight, but the US currently has no regulatory pathway for biosimilars. That could change after FDA releases its final guidance on follow-on biologics later this year. Read more »

Some drugmakers have blamed what they see as a slow and overly cautious FDA for the industry’s weak pipelines. Last week, I cited drug-approval figures to show that the agency was not standing in the way of innovation. A closer look at the figures contradicts another part of the critics’ argument—the industry’s pipelines may not be so weak after all. Read more »

The ICH Q11 guideline on the development and manufacture of drug substances may be one of the most  awaited regulatory guidelines in recent harmonization history. The concept for this guideline was developed in May 2008, and at the end of last month, June 2011, FDA published the Step-2 consensus document as draft guidance for industry comment. In general, the document aims to provide guidance on how industry can develop process and drug-substance (that is, chemical and biological entities) understanding. This guidance is important because of its focus on APIs—perhaps the most important component of any drug product—and because it addresses biopharmaceutical manufacturing, an area that is growing like wildfire in terms of R&D but has been somewhat stifled when it comes to global regulatory guidance. The document is also of great interest to industry because of its attention to “understanding”—a key concept of quality by design. Understanding of a drug-product’s materials and their functionality and characteristics is becoming more important and, in fact, is critical for any quality- or risk-based approach to bio/pharmaceutical manufacturing today. These types of approaches, promise the authorities, are meant to provide regulatory flexibility for manufacturers. Read more »

Facility rationalizations, outsourcing, and staff reductions can provide only so much of a cushion to pharmaceutical and biopharmaceutical manufacturers about to drop off the patent cliff. The ideal way to remain profitable is to discover and develop innovative new drugs, but this task has proven increasingly difficult for drugmakers over the past few years. Jonathan Leff, a managing director at venture-capital firm Warburg Pincus, says that FDA is partly to blame. Read more »

It’s not hard to find employees at large- or small-molecule drug companies who have gripes about FDA. On and off the record, people have complained that the agency’s review process is slow and that its decisions can be erratic. Perhaps hoping to make a positive contribution to this discussion, the Biotechnology Industry Organization (BIO) made several proposals last week for improving FDA’s operations. Read more »