"I have to wonder if the complete response letter were released publicly, would you wait to submit your application until it was really ready…?" asked John Jenkins, head of the Food and Drug Administration's (FDA) Office of New Drugs at a recent conference, suggesting a new level of transparency in the approval process might be approaching. Andrea Masciale, senior director of regulatory affairs for Johnson & Johnson, voiced industry concerns saying that any release would have to redact trade secrets… "The Internet and the people who use it are changing, and changing much more rapidly than the ability of the agency that regulates it," complains Eye on FDA's Mark Senak. As an example: real time search capabilities - similar to what Google is doing with Google Flu Trends - could "transform" pharmacovigilance for the FDA, allowing it to track searches about drugs and determine if problems are arising… Noting that only 3 to 5 percent of adult cancer patients participate in clinical trials, cancer physician Douglas Blayney throws his support behind the U.S. Senate's Brown-Hutchison Amendment to the health care reform bill that would require private insurers to cover patients' routine care if they participate in clinical trials. The amendment would also establish a federal standard prohibiting private insurers from discriminating against individuals with life-threatening diseases who choose to participate in a clinical trial.

 

 

"As Big Pharma switches from blockbuster medications that treat more generalized diseases ... to drugs with more individualized applications, orphan drugs could become more prevalent," says blogger Lisa LaMotta. And more significant to the bottom line. The global orphan drugs market is expected to reach $81.8 billion by 2011. The FDA is sponsoring two programs next year to educate industry insiders, as well as provide individual guidance on creating submissions for orphan drug designation… In the Pipeline's Derek Lowe reviews Bernard Munos' paper on the drug industry, noting that the cost of getting a drug to market has been increasing at an annual rate of 13.4% since the 1950s and that less than one-third of the industry has a cost per new molecular entity (NME) of under $1 billion dollars. Interestingly, Munos' found that "countries with a more demanding regulatory apparatus, such as the United States and the United Kingdom (UK), have fostered a more innovative and competitive pharmaceutical industry,” because they force companies to be “more selective in the compounds that they aim to bring to market…" A new "patent box" will introduce a 10 per cent corporation tax rate from April 2013 on UK patent income "to strengthen the incentives to invest in innovative industries." The pharmaceutical and biotechnology industries, which will eventually be the biggest beneficiaries of the patent box, welcomed it although others complained about the 2013 implementation date.

 

 

"The Internet isn’t chock full of reportable adverse events just waiting for the first unsuspecting pharma company to happen by and be crushed by the deluge," says Jonathan Richman. In a white paper, he and co-author Melissa Davies explain how pharma companies could monitor online discussions. "Companies need to determine what and why they are monitoring," they say. "Finding adverse events isn’t the only reason. Correcting misinformation, understanding patient needs, and engaging in dialogue (e.g., answering questions) are also reasons…"  "We've heard opinions of agencies and seen data from studies sponsored by agencies, but what are the views of real patients who have been using social media for years?" asks Pharma Marketing's John Mack. Gilles Frydman, founder of the Association of Online Cancer Resources (ACOR), an online community of cancer listservs, urged industry to get in touch with patients currently using social media for health information "and find ways to ask these people how to best communicate with them. If you do this, within 6 months you will be able to put together a document for the FDA that will mean something..." Americans are burnt out on risk communication from pharmaceutical companies, found ORC Guideline, in their October 2009 survey of American adults. Instead, people prefer simpler approaches through Web sites like WebMD and icons like the Consumer Reports' multishape "moons" to learn about health risks.

 

ACRO Supports Senator Sherrod Brown's efforts to require health insurance products to cover the routine costs associated with participation in certain clinical trials.