Reports of teenagers’ pharm parties, Rush Limbaugh’s OxyContin addiction, and the questions surrounding Michael Jackson’s death have kept prescription-drug abuse in the public eye. By requiring manufacturers of opioid drugs to create risk evaluation and mitigation strategies, the US Food and Drug Administration is seeking to reduce opportunities for drug abuse while keeping the therapies available to patients who need them. One pharmaceutical company suggests that, in addition to regulatory solutions, drug abuse could be curbed using drug-delivery strategies. Read more »

In the debate over establishing a regulatory pathway for biologics, the White House recommended this week to limit data exclusivity for biologics to seven years, according to a Reuters report. Reuters reported that the Office of Management and Budget Director Peter Orszag and Nancy-Ann DeParle, director of the White House Health Reform Office, sent a letter to Representative Henry Waxman (D-CA), chair of the House Energy and Commerce Committee, whose committee is considering biosimilar legislation, stating that seven years “strikes the appropriate balance between innovation and competition.” As would be expected, supporters of limiting exclusivity such as the Generic Pharmaceutical Association (GPhA) applauded the proposal while the Biotechnology Industry Organization (BIO) raised concerns. Read more »

German authorities busted a counterfeit-drug ring yesterday selling fake Viagra (Pfizer, New York) via Internet pharmacy websites, according to an Agence France-Presse report. After a months-long investigation involving 60 customs officers, seven prosecutors and 25 tax investigators, raids in five cities produced 46,000 counterfeit Viagra tablets, frozen bank accounts in Austria, Switzerland, Spain, Belgium, France, and Turkey, four confiscated luxury vehicles, 15,000 euros ($21,000) in cash, and four people in police custody. Read more »

Innovation, innovation, innovation .. and a call to focus on science and quality-by-design (QbD) principles. Such was much of the talk yesterday at this year’s AAPS National Biotechnology Conference in Seattle. Speakers discussed the tools the biotechnology industry will need for future innovation and how the industry must center on QbD principles, using lessons learned from small-molecule development and even nonregulated industries. Read more »

This month, lawmakers such as Senator Kent Conrad (D-ND) and Senator Edward Kennedy (D-MA) have introduced a flurry of healthcare-reform bills that provide for comparative-effectiveness (CE) research. Supporters of CE research say that it could cut unnecessary costs by identifying the treatments that produce the best results. Federal and state governments’ share of the national healthcare bill could consequently be lighter, yet critics fear that promoting CE research could give the government too much power over treatment. Read more »

The first-ever BRIC Economic Summit was held this week in Yekaterinburg, Russia, further signaling the importance of Brazil, Russia, India, and China, collectively known as the BRIC countries, in the current and future direction of the global economy. Some predict that the BRIC countries will surpass the leading economies by 2050, according to a recent New York Times article. The seeds of change already have been planted in the pharmaceutical industry, where pharmaceutical market growth in emerging economies is projected in the double-digits in 2009, compared with declining to anemic growth in established markets. Big Pharma is attuned to the shifting market dynamics. Many companies have clearly stated their strategic intent to enhance their positions in emerging markets. But what are the implications for pharmaceutical manufacturing? We may have gotten a glimpse into the future with some recent moves by Pfizer and GlaxoSmithKline (GSK). Read more »

“Geopolitical environmental scanning” seems to be the new catch phrase in supply chain security. The term came up multiple times during the ISPE conference and during the launch meeting of the Rx-360 consortium, both of which took place in Washington, DC, the first week of June.

IPEC–Americas Chair Janeen Skutnik mentioned geopolitical environmental scanning as a way to detect, in advance, potential weaknesses in or disruptions to the supply chain that could lead to contamination, adulteration, or counterfeiting. Read more »

The US Food and Drug Administration today warned consumers to stop taking three over-the-counter versions of Zicam, made by Matrixx Initiatives (Scottsdale, AZ). The company has received a Warning Letter, but a product recall has not been issued. Read more »

The debate over biosimilars was ratcheted up this week as members of Congress and industry responded to a Federal Trade Commission (FTC) report that examined the impact of possible incentives to promote competition for follow-on biologics (FOB). At the heart of the debate is the length of time for data exclusivity for biopharmaceuticals, with certain key members of Congress seeking reduced times and industry seeking to maintain at least the status quo. The debate raises questions not only on how to proceed in developing a regulatory pathway for biosimilars, but also addresses the larger issue of how measures may hinder or facilitate drug innovation. Read more »

For the first time in 41 years, the world is at the start of an influenza pandemic.  The announcement regarding raising the H1N1 influenza pandemic level from Level 5 to Level 6 came today from from Dr. Margaret Chan, director general of the World Health Organization. Read more »