The pharmaceutical industry does not have a good reputation among patients and consumers.

This may seem like an unfair situation given the fact that medicines produced by the pharmaceutical industry save millions of lives each year, but humans are far better at focusing on the bad things than the good, and recent recalls, controversial pricing policies and lawsuits have definitely given people reason to focus on the negative side of the pharmaceutical industry. Read more »

An important third party is struggling to make its voice heard in European pharma discussions. Drug pricing is not just a matter of manufacturers battling with health ministries, insist groups representing the end-users of medicines — that is, the patients. Over and above the questions of costs and bureaucracy, the more important issues of equity and patients’ rights are at stake. And these, according to patient groups, are critically threatened by delays in access to treatment. Read more »

Drug shortages are increasing at an alarming rate. Between 2005 and 2010, the number of drug shortages per year leapt from 61 to 178. This year’s total, 220 as of October, already surpasses that of last year. Fortunately, FDA has taken a step that is intended to prevent drug shortages from becoming crises. Read more »

FDA approved 35 innovative drugs in fiscal 2011, including treatments for hepatitis C, prostate cancer, Hodgkin’s lymphoma, and lupus. This number of approvals is among the highest in the past 10 years, and it reflects the agency’s efforts to hasten patients’ access to new drugs. In the past two years, the agency’s lower levels of approvals—21 drugs in 2010 and 25 in 2009—caused concern throughout the industry and in Congress. We may feel grateful to FDA, but we also should ask how the agency achieved this high number of approvals.

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A few weeks ago, Representative Michele Bachmann (R-MN) made waves by claiming that the vaccine for human papillomavirus could have dangerous side effects. She retreated from her remarks after the American Academy of Pediatrics said that they had no scientific validity. Makers of biopharmaceuticals might feel vindicated, but a recent poll emphasizes that Bachmann is not alone in her views. Read more »

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 »

In a decision handed down late last week, the US Supreme Court gave manufacturers of generic drugs significant legal protection from liability. In Pliva v. Mensing, the Court ruled that patients cannot sue these companies under state law for failing to warn them about the risks associated with their drugs. Although generic-drug firms may welcome the decision, I think it has unpalatable implications. 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 »

Big Pharma’s sales forecast is not likely to improve anytime soon. Consulting firm Bain and Company predicts that the top 25 drug companies’ annual sales growth will be no more than 1% through 2016. To compensate for reduced revenue, investors are urging manufacturers to cut expenses that do not add value. One such expense, in many investors’ eyes, is research and development (R&D). 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 »