According to an Associated Press report, Harvard researchers have been reviewing the recent rash of problems with approved drugs and have come to a "disturbing" conclusion: drugs that were approved by the FDA in a rushed timetable have had more problems than drugs that were approved on a more leisurely timetable.  The results of this research have just been published in Thursday’s New England Journal of Medicine and provide support for the researchers’ conclusion.

The Associated Press explains as follows:

Deadlines were first imposed on FDA by a 1992 law that allowed drug makers to pay millions of dollars in fees directly to the cash-strapped agency so it could hire more reviewers and clear a backlog of pending drug applications. In return, FDA had to make a decision — either approve or reject — on 90 percent of all drug candidates within 12 months of their application, or lose money. The deadline was 6 months for drugs so novel or potentially lifesaving to be classified high-priority.  Congress tightened the deadline for most drugs to 10 months in 1997.

Amid concern about risky drugs, Harvard professor Daniel Carpenter took a closer look at the impact. First, he found approval is 3.4 times as likely in the two months leading up to the user-fee deadline as at any other time.  Drugs approved in that just-before-deadline period had a four-to five-fold higher rate of later being withdrawn or requiring serious safety warnings, compared with drugs approved faster — presumably slam-dunks — or those that miss the deadline, Carpenter concluded.

While the FDA is denying that an accelerated review timetable is responsible for the recent wave of problems with approved drugs, the New England Journal of Medicine report certainly suggests that the contrary may in fact be true. 

In light of this evidence, what should be done to protect the public? 

Two possibilities quickly come to mind: first, there is the option of bulking up the FDA staff to more effectively deal with accelerated review timetables, and second, there is the option of lobbying Congress to loosen the tight deadlines, so that the FDA has more time to do a more thorough review of new drugs.  Given the current budget deficit, the second option is likely more realistic.

Perhaps patients who are pursuing class action suits against Merck and other companies who have sold these problem drugs should redirect their efforts towards lobbying for new legislation in Congress to relax the current FDA approval deadlines.  Taking this action–rather than pursuing class actions suits–may very well be the step most likely to produce real change in order to best protect the public. 

The event The Neurotechnology Industry Investing and Partnering Conference will be held on May 17-18, 2007 at the Westin, San Francisco Airport in Millbrae, CA.  This event is the premier partnering and investing conference for the neurotechnology industry including pharmaceuticals, medical devices and diagnostics. The event will provide a first-hand glimpse of What’s in the Pipeline

The event RX Drug Pricing Boot Camp on Thursday, May 17, 2007-Friday, May 18, 2007 at the Crowne Plaza Hotel in San Francisco, CA.  The event has been designed to give notices and  experienced practitioners alike a complete understanding of core pricing competencies and applicable changes in the reimbursement structures of key payor programs under recently enacted legislation.  The event will highlight the following:

• The Deficit Reduction Act and its impact on pricing methodologies relative to Medicaid and other payor programs.
• The role of the National Rebate Agreement in various payor programs.
• AWP: what is it, when is it still used, and what is its relationship to WAC?
• 340B entities: how are they defined and how is 340B pricing set?
• The essentials of Medicare Part B pricing, including the interrelation of ASP, CAP, and WAMP
• The ins and outs of government contracting relative to GSA FSS, VA/DOD, and Tricare
• Pricing concepts and reimbursement challenges relative to Medicare Part D, including: fraud and abuse risk areas — PAPs, off-label use, and Part D marketing guidelines; LTC pharmacies and PBMs; the position of CMS on legal issues affecting the drug benefit; formulary negotiations; and policy concerns.

The event How to Prepare a Budget? Identifying Key Assumptions, Statistical Inputs. . . .   will be held on Thursday, May 17, 2007 from 11:30 to 2:00 at the San Jose BioCenter, 5941 Optical Court, San Jose, CA  95138.

BIOCOM’s Monthly Breakfast Meeting: Private Equity Investing and Alternative Financing Models will be held on Wednesday, May 16th from 7:00 to 9 a.m: at Marriott La Jolla, 4240 La Jolla Village Dr., San Diego, CA  92037.  The speakers for this event will be as follows:

• Andrew L Busser, Principal, Symphony Capital LLC
• Kathy Conte, Managing Director, Hercules Technology Growth Capital
• Leigh P. Ryan, Partner, Chair of Corporate Department, Paul Hastings, Janofsky & Walker
• Matt Wotiz, Associate, Paul Capital Healthcare.

The early registration deadline for this event is May 14, 2007.

The event  Beta Amyloid as a Therapeutic Target for Alzheimer’s Disease: Where Are We After Twenty Years? will be held on Wednesday, May 16, 2007 from 6 to 9 p.m. at the Clarion Hotel, San Francisco Airport, 401 E. Millbrae Ave., Millbrae, CA  94030.  Ivan Lieberburg, PhD,  MD, Chief Medical Officer, Elan Clinical Professor of Medicine, UCSF will speak at this event about where we are in the fight against Alzheimer’s Disease.

The Practicing Law Institute event Handling Intellectual Property in Business Transactions will be held in San Francisco on April 30-May 1, 2007.  The event will cover the following issues:

• Strategies in creation of intellectual property assets;
• Obtaining ownership of intellectual property assets;
• Strategies for licensing of intellectual property assets;
• Trademark licensing and branding issues;
• Understanding and analyzing intellectual property assets;
• Maximizing the value of intellectual property assets;
• The impact of Sarbanes-Oxley and FAS 141/142 on IP issues;
• Critical open source issues; and 
• Protecting IP assets in the event of bankruptcy.

The ABA Science and Technology Section’s Biotechnology Law Roundtable Teleconference on Regulatory & Policy Implications of Personalized Medicine & Pharmacogenomics will be held from 8:30 a.m. to 10:30 a.m. PST on April 30, 2007.  The speakers for this event are Janet Woodcock, Deputy Commissioner & Chief Medical Officer, U.S. Food and Drug Administration, Rockville, Maryland, and Ellen Flannery, Partner, Covington & Burling LLP, Washington, D.C.  The event will explore the regulatory and policy issues that will arise as researchers, industry, and government regulators move towards implementing a pharmacogenomic approach to medical care.

The event HRx for Success–Strategies every Life Science Leader Should Know to Increase Company Performance will be held on Thursday, April 26, 2007 from 7 a.m. to 9 a.m. at the

The event NanoBioNexus’ Patenting & Licensing Nanotechnology–"Where Much Can Go Wrong if You Don’t Get it Right" will be held at the Radisson La Jolla, 3299 Holiday Court, La Jolla, CA  92037 on April 26, 2007 from 5:30 to 8:30 p.m.  The speakers will include:

• Vicki G. Norton, Ph.D., J.D., Partner, Intellectual Property, IP Litigation, IP Counseling & Patents, Life Sciences, Wilson Sonsini Goodrich & Rosati Law Firm;
• Esther Kepplinger, Director, Patent Operations, IP Counseling & Patents, Wilson Sonsini, Goodrich & Rosati Law Firm; and 
• Jane Moores, Ph.D.
  Interim Director, UCSD Technology Transfer.