Should FDA split safety ops from CDER?

This is a topic that comes up early in my GCP class at UC Santa Cruz Extension, when we do an overview of the FDA's operations and PDUFA as they pertain to good clinical practice.  PDUFA has over the years enabled a a more efficient and predictable pathway through the US regulatory review process.  Improvements are not without cost, and the consequences here have been felt on the continuing review of the safety of marketed medicines as budget has shifted to meet the Congressionally mandated trigger for user fees, and one option long under study has been to move safety evaluations altogether away from the evaluation of new drugs.


Bloomberg today has looked at the data since 1995 (PDUFA was first enacted in 1992) and reports that over half of the 21 drugs approved since 1995 have since been withdrawn from the market behind cardiovascular problems.  Armed with these findings, Sen Chuck Grassley (R-Iowa) is developing a bill with Rep. Rosa DeLauro (D-CT) to create a new Office of Surveillance and Epidemiology whose function - and one presumes budget - would be completely separate from CDER and its budgetary constraints, and its heavy reliance on voluntary post-marketing adverse event reporting.  FiercePharma has it all here, along with an interesting link to a story about Sen Grassley's plans to move from the Senate Finance Committee to Judicial.  You read it here second.


Next week I will be attending and speaking at this meeting, Managing Relationships with CROs in London, and then a couple of days off.  

FDA's HSP/BIMO Progress Report

The FDA has released a progress report on its Human Subjects Protection/Bioresearch Monitoring Initiative (HSP/BIMO).  In the 18 months since launch several new regulations and guidelines have been produced, including:

• IRB registration;
• Expanded access to investigational drugs;
• A new informed consent essential element notifying subjects of study registry on the clinicaltrials.gov system;
• The final guidance on 1572s;
• New guidance on investigator responsibilities;

And a whole bunch more.  Included in the report is an update from the FDA/Duke University Clinical Trials Transformation Initiative (CTTI), which includes among many other things a joint initiative between FDA and EMA for good clinical practice.  The EMA/FDA GCP terms of engagement and procedures document is here.  The HSP/BIMO report is here.

FDA Limits Action Against HIV Investigator

A story linked via FierceBioTech today from an article published last week in the Chicago Tribune describes the apparently light touch the FDA is using to discipline an investigator whose clinic allegedly submitted fictitious data in a clinical drug trial.  Standard procedure in such cases is usually either disqualification from running clinical trials altogether or restriction of the number of trials an investigator may conduct or the number of patients they may enroll.  This investigator, whose writings about HIV are easily searchable on the Web, apparently escaped all such restrictions and instead is allowed to continue clincal trial operations under the supervision of an outside medical monitor for the next three years and is required to submit annual reports to the FDA in that same three year period.  This seemingly light slap runs counter to the message being sent to drug manufacturers themselves for whom the agency is stepping up its oversight with warning letters, product recalls and threats of prosecution, according to the Fierce story. 

Switching gears entirely, here is a link to the OHRP's 2010 International Compilation of Human Research Protections.  This is an absolutely invaluable resource covering the key organizations, legislation, regulation and guidelines pertaining to human subjects protection of 96 countries, updated every year with clickable links.  Every clinical research professional planning studies anywhere in the world including the emerging regions should make this document their first stop. 

Roche Jobs Shift to China

As a former Roche employee (and holder of a pension) my eye is always drawn to stories about changes at that company.  Last week they announced a major cost cutting effort in the US and Europe, letting slip an internal memo naming the employees responsible for each sector.  This week they are announcing a hiring boon in China, increasing headcount there by as many as 750 jobs.  This appears to be the sharp end of the stick in China that we have been watching for, as the Chinese government invests in its drug development capacity and more large sponsors move in to establish operations.  The Fierce article notes that Eli Lilly announced thousands of layoffs last year while staffing up in China.  I think this puts India under some pressure, as clinical trial application approval times there have slipped into 120 days and more, a not very welcoming gesture to sponsors interested in running clinical trials there and have the means to ensure patient safety and ethical conduct.

FDA's Marketing Crackdown

There has been a lot of news about the FDA cracking down on drug makers advertising direct to consumers, which is either a) poor ethical behavior or b) an indispensable way to educate the marketplace, depending on your biases.  I tend to lean toward the former.  Anyway FiercePharma has been following this issue closely, and has an item here worth checking out.

I read this blog from Steven Grossman called FDA Matters, which I found via GxP Perspectives.  The whole FDA is covered not just drugs, so I pick and choose the articles within my wheelhouse. Take a look.

I have a few more speaking engagements coming this year:  Managing CRO Partnerships in London October 4-5, and MAGI West in San Francisco October 24-27.  See the sidebar for links and details.

Also I will be moderating a panel at Astia's Silicon Valley Doing It Right session in San Francisco November 5.  Astia is a program that provides resources and training for women entrepreneurs in life sciences, technology and clean tech.

The fall term starts at UC Santa Cruz extension today; 10 weeks of GCP class.  It's not too late to sign up.

We've Hit the Big Time!

Two Decades just got listed on this posting at GxP Perspectives as a blog "well worth checking out".  Thanks Carl!