"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.

 

 

While most are focused on the passing of healthcare reform legislation this month, of more importance to the FDA is work on next year's budget. FDA Matters' Steven Grossman says it’s going to be a rough year for FDA funding for many reasons: unfunded mandates, like food safety and follow-on biologics; the FDA getting "lost" in the funding and implementation of healthcare reform; and past year increases seen as good enough… Germany's Institute for Quality and Efficiency in Health Care (IQWiG) is taking a couple of swings at the UK's National Institute for Health and Clinical Excellence's (NICE) methods, reports the IN VIVO Blog. IQWiG's new method doesn't impose a uniform upper cost threshold across all diseases, like NICE's £30,000-per QALY (quality-adjusted-life-year) guideline limit, instead comparing "the relation between cost and benefit for each individual disease." But, notes the blog, IQWiG has no teeth. It can only make recommendations and health insurers can either follow those recommendations, or not… Why are 70 percent of standard new molecule entities (NME) applications not approved by the Food and Drug Administration (FDA) on first action? Director John Jenkins of the FDA's Office of New Drugs points the finger at industry's poor research productivity. But Mary Pendergast, consultant and former deputy FDA commissioner, argues that maybe one reason it's so much harder to get the second, third, fourth, and fifth drugs in a class approved these days stems from FDA's desire to see superiority data. "What we are seeing - and should be paying attention to - is [the emergence of] stealth comparative effectiveness," she claims.

 

 

On November 12 & 13, the FDA held public meetings to gather input on the "Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools." A Web site by igniteHealth , a health marketing agency, is collecting all information about the meeting, including presentations from the event, news stories and tweets… Bloggers and other members of the media are weighing in on the meetings. Advertising Age agrees with the Pharmaceutical Research and Manufacturers of America's (PhRMA) proposal to create a logo that could be placed on social sites to indicate where information that meets the FDA's guidelines would be available… Health Populi's Jane Sarasohn-Kahn reports that in a recent survey, "health activists" said that social media can play a valuable role in four key aspects of health communication: to provide product updates, to bring accurate information into (online) conversations, to address common questions, and to add professional expertise…  Eye on FDA's Mark Senak is skeptical. "The FDA has gone to great lengths to assure a new transparency," he says. "That's new FDA.  Not letting us know next steps around the social media guidance - that's old FDA," he complains, referring to the lack of specificity at the end of the meeting and the time lag until a guidance emerges. "The public health threats caused by the status quo are clear. Do we really have to wait months and months for answers?"

 

 

In a meeting slated for this week (November 12 &13), the Food and Drug Administration's (FDA) Risk Communication Advisory Committee will gather input on how to improve the reporting of clinical trial results on the National Institutes of Health (NIH) clinical trials registry and results database, ClinicalTrials.gov. Specifically, how to "enhance public understanding of the limitations of trial-level data" and how to best present the data in layperson's terms… China promised to continue to strengthen its "oversight and enforcement of active pharmaceutical ingredients (APIs) and counterfeit pharmaceuticals" in discussions during the 20th U.S.-China Joint Commission on Commerce and Trade in late October. China said it's State Food and Drug Administration (SFDA) will be the single point of contact for the Interagency Coordination Conference (ICC) for Fighting the Production and Sales of Counterfeit Drugs and will share information with the U.S. FDA… "The importance of animal research needs to be a core value for FDA" and other stakeholders, argues FDA Matters' Steven Grossman, writing about a bill in the U.S. House of Representatives (HR 1326) that would "virtually eliminate" research using chimpanzees. "Those who benefit from animal research (including patients) need to provide the manpower and financial resources to counter the animal rights movement in America and its threat to medical progress for humans."

 

 

CRO PPD will participate in one of several Food and Drug Administration (FDA) initiatives aimed at improving patient safety. Under the contract, PPD will participate in the Initiative for Maximizing the Benefit of Passive Adverse Event Collection throughout a Product’s Lifecycle (IMPACT) and provide data to help the Agency develop an implementation strategy to optimize use of the surveillance system as part of its pharmacovigilance efforts… The FDA Law Blog has provided a summary of items that are of direct interest to pharmaceutical and medical device manufacturers in the most recent U.S. House of Representatives health care reform legislation (H.R. 3962), including the impact on biosimilars and comparative effectiveness research... The European Union's Medicines and Healthcare products Regulatory Agency (MHRA) plans to increase its licensing fees just 1% from next April, as opposed to initial projections of 3%-4%. The MHRA forecasts that it will spend £36 million (US $59 million) on medicines licensing work during 2010-11, £3 million (US $4.9 million) on the regulation of clinical trials, £1 million (US $1.6 million) dealing with manufacturer and wholesale dealer license applications, variations and export certificates, and £8 million (US $13.1 million) on conducting inspections.

 

 

The first industry standard for Chinese clinical research organizations (CRO), Guidelines for Clinical Trial Services of Contract Research Organizations is likely to be introduced before the end of this year by the Contract Research Organization Union China (CROU). The guidelines have been formulated with references to relevant industry and governmental documents…  A report from the U.S. Government Accountability Office (GAO) finds the FDA has failed to follow up on drugs that were made available through an accelerated approval process. The FDA says the program has "significantly improved (patients') quality of life and survival" and "in the vast majority of cases, the confirmatory trials have been or are being completed in a timely fashion, have confirmed clinical benefit, and have led to conversion to regular approval..." "FDA needs to define regulatory science, develop programs to support it, and package them in a way that will quickly bring recognition and funding," stresses blogger Steven Grossman, encouraged by Commissioner Hamburg's recent emphasis on regulatory science. Grossman proposes the creation of the Center for the Advancement of Regulatory Sciences (CARS) at FDA, "to be a starting point for discussing how advancement of regulatory science can become integrated into FDA’s mission."

 

 

The Food and Drug Administration (FDA) may recommend that cancer vaccine trials include healthy individuals as well as cancer patients. "Concern has been expressed that cancer vaccine trials, which cannot recruit through the usual investigator channels, will take significantly longer than is the case today," said patient recruitment specialist Synexus. While FDA guidance documents are not mandatory, adhering to them can help the registration process go smoother… In a closely watched case of drug pricing, the European Court of Justice has ruled in favor of GlaxoSmithKline saying that "regulators should reconsider whether efforts by drug makers to prevent traders from exploiting price differences across Europe should be allowed." The court also supported a lower court judgment that found the commission had inadequately examined Glaxo's request for an exemption from the antitrust rules on the grounds that the higher prices would encourage pharmaceutical research…" The European Medicines Agency has begun implementing a series of changes to its internal organization aimed at improving the functioning of the agency. Some key changes: the life-cycle management of medicines for human use will be brought together into one unit; and creation of a single sector for the management of product data and documentation related to applications for the whole agency.

 

 

"FDA inspections and compliance efforts will ... focus on inspecting firms and products that have histories of noncompliance and where problems with the products could cause serious health consequences for consumers," said FDA compliance directors at the recent FDA Enforcement and Litigation Conference. Two areas of concern: poor adverse event reporting systems and failing to comply with manufacturing specifications… As the FDA gets ready for its November 15th meeting on social media, blogger Mark Senak questions if the agency is going about it the right way. "What is lacking here are more fundamental questions about how the Internet differs from other forms of media today, and where the Internet is headed tomorrow," says Senak. But while the FDA's questions are valid it also needs to "consider the evolution of the Internet with potential game changers like Google Wave and Google Sidewiki, and to anticipate the continued integration of social media…" After the FDA's warning letters in March 2009 to 14 drug makers about sponsored link ads for specific drugs (cited as misleading because risk info wasn’t included), sponsored link exposures dropped 84 percent overall from March to June, reports comScore. Still pharmaceutical companies' internet promotion spending was up 16 percent from a year ago.

 

 

"Safety will become old news," says Robert Goldberg of the Center for Medicines in the Public Interest. "What's new is deadly delay." As Food and Drug Administration (FDA) delays move to the forefront, regulators and drugmakers will be forced to address technological and regulatory obstacles, says Goldberg. Among the key issues the FDA faces are regulatory standards for generics, personalized medicine and regulatory science… A Senate floor amendment to the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of 2010 (H.R. 2997) would require the FDA to establish a review group within the agency to recommend "appropriate preclinical, trial design, and regulatory paradigms and optimal solutions for the prevention, diagnosis, and treatment of rare diseases…”  The FDA has said it will draw up new rules on Good Manufacturing Practices (GMP) for companies developing products that are based on drugs, biologics or medical devices in combination. A significant change is that manufacturers may no longer have to adhere to GMP requirements for single-entity combinations and co-packaged combinations.