As I See It
By opposing making clinical trial data public, Pharma is once again swimming against the current
CMS recognized that the rules in place for CME provide for separation from supporter influence
Just like the NSA can monitor national security, FDA market-watchers can track what pharma marketers are doing.
While there are successes in the battle for better adherence/compliance, we're losing the war
Appendages of the HHS secretary's apron strings, FDA commissioners must toe the "party line"
People in the industry must be worried about the type of care doctors are now giving
While we all like the sun, life under the final rules for the "Sunshine Act" provisions of the Affordable Care Act is going to be complicated and treacherous for drug companies and their agencies.
FDA has never won a First Amendment case, and its string of losses led it to bring this one under false colors
The image of pharma as corrupt is not a problem of perception. It's one of fact.
Major provisions in the FDA Safety and Innovation Act could make the approval process more transparent
Neither FDA nor its HHS masters seem to know how to develop an effective regulatory scheme
Part D is the Michael Phelps of healthcare reform—providing a roadmap toward real evolution
Companies who submit proprietary data to FDA have a right to ensure it isn't disclosed to competitors
It was once thought bizarre to foist a commitment to innovation on a regulatory agency. No longer!
Social media is messy and the regulatory framework is equally so. Get used to it.
There are claims that a politically independent FDA belongs in "a world that doesn't exist any more"
Apparently, unless the rules explicity prohibit a specific type of unethical behavior, you're OK
It's time for a regulatory Marshall plan to help build global systems for quality and safety
Political interference in FDA's scientific decisions is growing, well-hidden phenomenon
Watching pharma executives, sometimes you have to wonder, "Will these guys ever learn?" Case in point, industry's assault on the FDA's conflict-of-interest rules.
Risk management means more than REMS strategies and tactics, or validated methodologies and therapeutic registries. What it's really about is assuming the mantle of responsibility.
Anti-corporation protests on Wall Street and beyond send a message that pharmaceutical marketers and regulators alike should ponder.
As companies prepare to report payments under the Physician Payment Sunshine Act, there are significant concerns.
Social media for regulated industry is a green field of opportunity. But to maximize the opportunity, we must accommodate the reality of a messier world. Social media, is messy and the regulatory framework (or lack thereof) is equally so. Get used to it. Embracing social media means embracing regulatory ambiguity.
A reported FDA plan, secretly developed to enforce the rarely used 36-year-old "strict liability" Park Doctrine against Forest Laboratories CEO Howard Solomon, reflects a poorly performed balancing of interests--given that the agency always forgives itself for the transgressions of its own subordinates.
Even a cursory review of FDA's April 28, 2011 Federal Register Notice, soliciting comments on several proposed consumer studies testing different ways of presenting benefit and risk information in online DTC prescription drug websites, reveals how far away FDA is from issuing guidance on key issues of concern to industry. A conspicuous example is the use of hyperlinks to provide risk information.
There's a generational element to the failure of the Obama administration's much-hyped agenda to increase transparency at government agencies like FDA, where reform has been submerged by bureaucratic resistance.
"Newspeak," as Orwellian cognoscenti know, is the official language of Big Brother, designed "not to extend but to diminish the range of thought."
Everything in life is inherently risky. Each day, thousands of people are injured driving on roads or walking on public streets.
In January, FDA announced the launch of a new "FDA Basics for Industry," the most promising of its faltering transparency steps to date.
Did you miss January's Top 40 Healthcare Transformers issue? Read how these inventors, strategists, entrepreneurs and wonks are challenging, disrupting and otherwise transforming the healthcare business. And join us April 30 to honor them at the Transforming Healthcare Dinner. Click here.
- US pharma market value projected to be $550 billion in five years
- Lawmakers propose allowing pharma companies to share some off-label information
- Biosimilar uptake will require companies to tell a trustworthy backstory
- Everyday Health buys rare-disease agency Cambridge BioMarketing
- Apple's ResearchKit: Five Guidelines for Pharma