The pharmaceutical industry has sometimes been slow to embrace ideas that promise great practical benefits. The industry’s ingrained aversion to risk is partly to blame, but it’s usually not the whole story. Take the quality-by-design (QbD) initiative, which posits that the better a company understands a product’s quality attributes, the more likely that product will be safe and efficacious. The industry has generally supported this initiative, and Pfizer has brought it into the spotlight. 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 »

It’s a well-known fact that new product approvals in the pharma industry have been in decline in recent years. In 2010, for instance, the FDA only approved 21 new drugs compared with 26 and 24 in 2009 and 2008, respectively. July 2011, however, saw the FDA approve its twenty-first product for 2011 with AstraZeneca’s blood-thinner Brilinta, so it seems as if the agency is set to outpace 2010’s dreary approval numbers. 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 »

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 »

In 2010, the US House of Representatives’s Committee on Oversight and Government Reform held two hearings after scandalous cGMP violations at McNeil’s Puerto Rico facilities came to light. Former FDA Deputy Commissioner Joshua Sharfstein told the Committee that the agency would review McNeil’s plan for correcting deficiencies to ensure that the corrective actions were effective. “FDA intends to keep a close eye on these facilities until the company earns our confidence back,” said Sharfstein. Read more »

FDA issued this week a notice in the May 10th Federal Register in which the agency is requesting input from stakeholders and the public on a proposed user-free program for biosimilar and interchangeable biological product (i.e., Sec. 351 (k)) applications. The call for input on biosimilar user fees, a mechanism to fund regulatory review, is another step toward the development of a US regulatory pathway for biosimilars. Read more »

Concern about the federal government’s budget deficit is reaching a crescendo. Assorted Cassandras warn that failing to address this problem could have dire consequences, and members of both parties seem to agree that spending must be cut. But before Congress tightens its purse strings too zealously, I’d like to remind it of the valuable and necessary work that the national budget funds. Two drug-related stories that emerged last week provide particularly good examples. Read more »

Mention New Jersey to someone on the street, and he or she is likely to think of Springsteen, the Sopranos, or (God forbid) Snooki. But PharmTech readers know that New Jersey is an important state for the drug industry. Many big companies, such as Johnson and Johnson, sanofi-aventis, Novartis, and Pfizer, have headquarters or other offices in the state. And the Garden State’s drugmakers are facing the same difficulties that confront the industry at large. Read more »