As I See It

As I See It: Transparency and clinical trial data

As I See It: Transparency and clinical trial data

By opposing making clinical trial data public, Pharma is once again swimming against the current

As I See It: The Sunshine Act's CME exclusion

As I See It: The Sunshine Act's CME exclusion

CMS recognized that the rules in place for CME provide for separation from supporter influence

As I See It: Dealing with the Surveillance State

As I See It: Dealing with the Surveillance State

Just like the NSA can monitor national security, FDA market-watchers can track what pharma marketers are doing.

As I See It: The battle for better compliance

As I See It: The battle for better compliance

While there are successes in the battle for better adherence/compliance, we're losing the war

As I See It: Activism and the FDA

As I See It: Activism and the FDA

Appendages of the HHS secretary's apron strings, FDA commissioners must toe the "party line"

As I See It: the Sunshine Act

As I See It: the Sunshine Act

People in the industry must be worried about the type of care doctors are now giving

As I See It: Life under the "Sunshine Act"

As I See It: Life under the "Sunshine Act"

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.

As I See It: FDA and the First Amendment

As I See It: FDA and the First Amendment

FDA has never won a First Amendment case, and its string of losses led it to bring this one under false colors

As I See It: Pharma's public image

As I See It: Pharma's public image

The image of pharma as corrupt is not a problem of perception. It's one of fact.

As I See It: What the election means for FDA

As I See It: What the election means for FDA

Major provisions in the FDA Safety and Innovation Act could make the approval process more transparent

As I See It: Regulating compounders

As I See It: Regulating compounders

Neither FDA nor its HHS masters seem to know how to develop an effective regulatory scheme

As I See It: Dealing With the Mandate

As I See It: Dealing With the Mandate

Part D is the Michael Phelps of healthcare reform—providing a roadmap toward real evolution

As I See It: FDA whistleblower

As I See It: FDA whistleblower

Companies who submit proprietary data to FDA have a right to ensure it isn't disclosed to competitors

As I See It: FDA's commitment to innovation

As I See It: FDA's commitment to innovation

It was once thought bizarre to foist a commitment to innovation on a regulatory agency. No longer!

As I See It: Social media

As I See It: Social media

Social media is messy and the regulatory framework is equally so. Get used to it.

As I See It: The threat to FDA independence

As I See It: The threat to FDA independence

There are claims that a politically independent FDA belongs in "a world that doesn't exist any more"

As I See It: Ghostwriting

As I See It: Ghostwriting

Apparently, unless the rules explicity prohibit a specific type of unethical behavior, you're OK

As I See It: Global systems for quality and safety

As I See It: Global systems for quality and safety

It's time for a regulatory Marshall plan to help build global systems for quality and safety

As I See It: Political interference in FDA

As I See It: Political interference in FDA

Political interference in FDA's scientific decisions is growing, well-hidden phenomenon

As I See it: Conflict-of-interest rules

As I See it: Conflict-of-interest rules

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.

As I See It: Risk management

As I See It: Risk management

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.

As I See It: Anti-corporation protests

As I See It: Anti-corporation protests

Anti-corporation protests on Wall Street and beyond send a message that pharmaceutical marketers and regulators alike should ponder.

As I See It: the Physician Payment Sunshine Act

As companies prepare to report payments under the Physician Payment Sunshine Act, there are significant concerns.

As I See It: Embracing social media—and regulatory ambiguity

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.

As I see it

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.

As I see it

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.

As I see it

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.

As I see it

"Newspeak," as Orwellian cognoscenti know, is the official language of Big Brother, designed "not to extend but to diminish the range of thought."

As I see it

Everything in life is inherently risky. Each day, thousands of people are injured driving on roads or walking on public streets.

As I see it

In January, FDA announced the launch of a new "FDA Basics for Industry," the most promising of its faltering transparency steps to date.

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