As I See It: Patient Centricity

As I See It: Patient Centricity

A patient who is diagnosed earlier and receives the most efficacious treatment is the least expensive

As I See It: FDA's social-media moves

As I See It: FDA's social-media moves

FDA has insisted that its antique regulations can address every new promotional challenge

As I See It: FDA and marketing materials

As I See It: FDA and marketing materials

The more clarity that FDA provides, the more confident companies can be in their medical communications

As I See It: Access to data

As I See It: Access to data

We need for pharmaceutical companies to come forward and make the pledge to stop hiding data

As I See It: FDA and the First Amendment

As I See It: FDA and the First Amendment

FDA's Warning Letter to Aegerion is a bureaucratic thumb in the eye to the US Court of Appeals

As I See It: Small is the new Big

As I See It: Small is the new Big

It's fast becoming an n of 1 world, where every disease is an orphan disease and success is measured by individual outcomes

As I See It: Quality programs

As I See It: Quality programs

Keeping up with quality programs often feels like a safari in a jungle of government paperwork

As I See It: FDA reorganization

As I See It: FDA reorganization

Could PAG change the FDA inspection paradigm from honest, objective assessments to faster, easier ones?

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.

As I see it

While there has been a flurry of proposals to repeal, change or fix the Affordable Care Act, many stakeholders have come together to repeal the Independent Payment Advisory Board (IPAB).

As I see it

The FDA's many initiatives on risk management are confusing to the industry--and the problem is, in many ways, of the agency's own making. We need better risk management management.

As I see it

FDA's traditional internal secrecy cracked ever-so-slightly open in September, when it announced its long-awaited decision on the uncertain risks of GlaxoSmithKline's plummeting blockbuster, Avandia, for diabetes.

As I see it

That Britain is proposing the most radical reorganization of the National Health Service (NHS) since its establishment in 1948 is significant and sobering--but not surprising.

As I see it

Over 30 years ago a gregarious Congressman from Louisiana gave me and others some off-the-record advice on how to succeed on Capitol Hill.

As I see it

Federal agencies like FDA are moving creakily, if at all, to implement the "open government" mandate from the Obama administration as old practices continue and in some cases solidify.

As I see it

Those who call for FDA to adopt comparative effectiveness as a regulatory third leg are on a cost effectiveness jihad.

As I see it: transparency

So how's it workin' out for ya--all this new Obama transparency stuff?

As I see it: DDMAC elevated to OPDP

If you or your clients have sent promotion materials to FDA recently for pre-publication review, or--God forbid--have been the recipient of a DDMAC Warning Letter, you know that FDA's DDMAC has assumed a very aggressive enforcement posture.

As I see it: podium policy

"Podium policy" (when regulators give speeches or interviews that announce new regulatory expectations) is never a good idea.

As I see it: transparent government

More than a year has elapsed since the Obama administration first promised a more transparent government, but all we have seen at the FDA is an elongated public input gathering process by the Transparency Task Force on the expectations of the agency's numerous diverse constituencies.

As I see it: FDA and social media

Having held the Super Bowl of Part 15 hearings on social media, the big question is, what's the FDA's next move?

As I see it: healthcare reform

As healthcare reform moves through Congress, power moves from the hands of committee chairmen to the speaker and the Senate majority leader, who will decide, with little input, what stays in and out of the final bills.

As I see it

By getting back to basics, the FDA's new leadership says its first priority is to restore public confidence in an agency whose public esteem has never been lower.

As I see it: Search engine regulation

Until earlier this year, most drug manufacturers had been operating under the same policy relating to the use of sponsored links on search engines as had advertisers for other categories of products.

As I see it: Branded vs. non-bioequivalent generic drugs

Permit me to share some personal information—my eldest son has epilepsy. The good news is that his condition is under control due to the wonders of modern medicine.

As I see it: Don't knock new drugs until you try them

Often we hear of the dangers surrounding industry physician collaboration—that drugs can be "over prescribed," and that new drugs cost more than old ones. But there is another side to that story—new drugs save lives.

As I see it: Reorganizing the FDA means sweeping changes

Whether or not Congress elects to reorganize the FDA, the Obama Administration's new leadership team at the agency vows sweeping changes are on the way, from drug safety to more transparency in everything the agency does.

As I see it: Discussions on the DTC moratorium

Yogi Berra had it right when he said, "It ain't over 'til it's over."

As I see it

The Obama administration's flurry of "change" announcements included apparent backsliding on his spectacularly successful election campaign's "no lobbyists in my administration" pledge.

As I see it

With the FDA flailing and everyone impressing upon the Obama transition team how important their choice for commissioner will be, few acknowledge how impotent this post has become over the years.

As I see it

As the Obama transition team focuses on the nation's highest priorities, don't think for a moment that drug marketing issues will get a pass come Inauguration Day.

As I see it

Add to all the other Washington unravelings of the past nine years the loss of FDA innocence.

As I see it

Although feelings in the mainstream drug industry will be mixed, it's time to end the secrecy that surrounds the FDA's decision-making on approving drugs.

As I see it

Although feelings in the mainstream drug industry will be mixed, it's time to end the secrecy that surrounds the FDA's decision-making on approving drugs.

As I see it

Another bad idea from government policy wonks surfaced in July when an FDA enforcement director told the Wall Street Journal his agency is using press releases as a vehicle for serving notice on certain companies that they are out of compliance with regulations, and to get their acts together.

As I see it

As a new study finds that pharma has become Washington's largest lobby in terms of dollars spent in campaign contributions, a high-stakes battle is looming in the heat of election season over what those dollars can buy—defeat of new advertising curbs, blockage of drug imports from Canada and Mexico, stronger patent protections and more.

As I see it

The worst fears of the drug industry—that state attorneys general (AGs) will add their muscle to the FDA's in marketing enforcement—may be seen in Merck's recent $58 million settlement of state consumer fraud claims arising from the marketing of since-withdrawn Vioxx.

As I see it

The worst idea on Capitol Hill right now involves giving the FDA control of tobacco.

As I see it

The lower the FDA sinks in public esteem, the more it shows a bunker mentality, withdrawing into its shell and stalling on media inquiries.

As I see it

As the Bush administration prepares to eke out its last months in office, there is a sense of urgency that it should leave a judicially backed policy that FDA approval pre-empts state laws on product liability.

As I see it

While alarms were being sounded on Capitol Hill about the dire state of the FDA after a recent Science Board report said American lives are at risk, and a Government Accountability Office (GAO) investigation confirmed the agency's incapacity to intercept contaminated medical imports, the Bush administration in February proposed a 5.7% budget increase.

As I see it

Barely a month after the FDA's Science Board Advisory Committee unanimously declared that "American lives are at risk" because of a growing crisis in the agency's ability to meet its responsibilities, President Bush in December quietly signed into law a huge increase in the agency's budget—$79 million or nearly twice the raise he had asked for.

As I see it

Signs are everywhere that Washington is preparing for the next administration, whatever color it may be.

As I see it

As the Bush administration winds down, its agenda has brought some not-so-conservative results for drug marketers.

As I see it

The FDA's formal public examination of a third class of drugs for the US, between Rx and OTC, sets the stage for a bruising battle between an industry that has always fought the concept and the pharmacy profession which has yearned for it as a professional enhancement long established elsewhere.

As I see it

The FDA's formal public examination of a third class of drugs for the US, between Rx and OTC, sets the stage for a bruising battle between an industry that has always fought the concept and the pharmacy profession which has yearned for it as a professional enhancement long established elsewhere.

As I see it

Many were waiting to see if and when the new FDA commissioner would make a significant difference in the agency's defensive, stonewalling posture.

As I see it

Resource-strapped though it is, the FDAs DDMAC is expanding its surveillance to cover the industrys growing use of Internet blogs and product placements in popular TV shows.

As I see it

Look for more Avandias. Regardless of the anti-diabetes drug's medical merits, the recent furor surely opens an era of politico-medical soap operas that will ensnare other drugs.

As I see it

The FDA's own little "Avandiagate," complete with Nixonian "dirty tricks," emerged in May's mass media coverage of the editorial decision at the New England Journal of Medicine to rush online publication of preliminary safety data on this GlaxoSmithKline diabetes top-seller.

As I see it

Transparency is the new buzz word in Washington. After six-and-a-half years of the most secretive administration in living memory, this shouldn't surprise anyone.

As I see it

Along with high-level apologies for competency failures in the Office of the Attorney General, VA hospitals, FEMA, FBI and many others, we may add the FDA, previously the world's "gold standard" of health product regulators.

As I see it

Is drug advertising responsible for the FDA's loss of public confidence?

As I see it

Now come the ad police to ask for user fees from marketers. Admittedly, it's just for TV ad previews, but the FDA's Prescription Drug User Fee Act 4 reauthorization proposal may be seen as the thin end of the wedge — and the dawn of a new era.

As I see it

The Democratic Congressional majority's "first 100 hours" of unilateral legislative action before it goes bipartisan includes only one drug item—giving the government price negotiating authority for Medicare drugs.

As I see it

Reality stared pharmaceutical marketers in the face after the mid-term elections.

As I see it

Keep your eyes on the Democrats' government reform chairman, Henry A. Waxman, when the new Congress convenes.

As I see it

To show, or not to show?

As I see it

At the FDA-industry interface, how close is too close?

As I see it

While some in the pharmaceutical industry think there is altogether too much public focus on drug risks at the expense of drug benefits, it may be argued that, if true, that is a consequence of the way the post-marketing drug experience is set up.

As I see it

Political meddling in the FDA's scientific decision-making, which began under President Clinton, seems to have cost the agency dearly in public opinion, judging by a recent poll.

As I see it

Women wept in the streets when the FDA's first commissioner left office in 1912.

As I see it

President Bush's nomination of Andrew von Eschenbach in March to be the FDA's permanent commissioner immediately ran into a brick wall.

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MM&M EBOOK: PATIENT ACCESS

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