Regulatory

Only time will reveal CER's true definition, and determine the full effects of a CER-based system

Approvable letters delay NDAs, cost pharma plenty, and are at an all-time high. Industry says FDA is gun-shy; the agency says it's business as usual. Who's right?

A landmark court case in the United Kingdom has left Alzheimer's patients with mild to moderate disease unable to receive any of the three drugs that might help them-Aricept (donepezil), Reminyl (galantamine), and Exelon (rivastigmine). Eisai and Pfizer, which make and market Aricept, had challenged the ruling made last year by the National Institute for Clinical Excellence that the drugs should be prescribed only to patients in the later stages of the disease. They were granted a judicial review-the first time one of NICE's decisions had been challenged in this way-and while the judge upheld one part of the challenge, the other two parts were dismissed and NICE's guidance stands.

The history of prescription drug laws is a complex mix of evolution and politics-in particular, the politics following real or perceived public health crises. The bipartisan PDUFA IV legislation currently pending in Congress is no exception: The bills-the Senate FDA Revitalization Act (S. 1082) and the House FDA Amendments Act (H.R. 2900)-would both continue existing programs and create new regulatory burdens.

Much has been said about the need and imperative for life science companies to comply with the various laws and regulations that govern our industry. More recently, state-level marketing laws have proliferated, adding new rules of the road and resulting in thousands of hours and millions of dollars for training, tracking, reporting, consulting, analysis, and support systems.

Twelve years is probably "the best deal the industry is going to get," comments former FDA official Scott Gottlieb. "This is a genuine compromise."

Although pricey, serialization with RFID is expected to reduce logistical errors and address some aspects of supply chain security

We'll see a more coordinated, worldwide platform not just for marketing, but for R&D and regulatory because of the harmonization that is slowly coming, primarily between Japan, Europe, and the United States

There's tremendous opportunity for us to understand how drugs can be used even better to get the right outcome, not only how to contain them in order to avoid complications or adverse events

As the industry focuses its attention on the upcoming renewal of the Prescription Drug User Fee Act (PDUFA), there is a tendency to overlook two other significant pharmaceutical programs coming up for renewal and a related piece of legislation that has been introduced:

Innovation in science is no quick trick, and neither is collaboration. Back in March 2004, FDA sounded a now-famous alarm: Despite the drug industry's 250 percent jump in spending on R&D, drug-development productivity had plunged by 50 percent over the previous decade. The report, which became known as the Critical Path Initiative (CPI), last year yielded an industry-wide call to arms regarding 76 action items (aka, the "Opportunities List") in six key areas: biomarker development, the streamlining of trials, the harnessing of informatics, improving drug manufacturing, public health initiatives against infections and bioterrorism, and special programs for adolescents, children, and other at-risk populations.

The Sarbanes-Oxley Act-or SOX, as it is dubbed (not always so affectionately)-requires companies to provide greater control and quality assurance across a vast spectrum of business processes. In practice, SOX plays out differently industry by industry and even company by company. But for pharma, one of the most pressing consequences is the need to improve the accuracy of revenue recognition.

The UK's 'unsystematic' healthcare structure is getting a makeover. It includes a new single body to oversee drug development, and potential incentives for pharma-if it plays nice.

Democrats want more transparency from pharma, and Republicans also are making noise about pricing. But government drug reimbursement is hard to get right and often creates perverse patient care incentives.

A new GAO report sets out to explain why drug development is so expensive and what to do about it. What the report says is important, but what it leaves out is a sense of how the world of pharma actually works.

In Germany, the eight million richest citizens contribute nothing to the system that pays for the remaining 70 million insured people.

A free flow of cheap counterfeits eclipses the ability of local manufacturers to create new products.

There are lots of politicians, Senators Grassley and Waxman to name just two, who often say FDA is in the pharmaceutical industry's pocket. But anybody that has ever worked with FDA realizes not only is that not right, it's comically wrong.

The Medicare Modernization Act set the stage for rapid and easy conversion to government-controlled pricing and the adoption of government pricing by private payers.

Who should make decisions about drug safety-FDA or patients and doctors? In this excerpt from his important new book Overdose, the renowned (and ever controversial) legal scholar Richard A. Epstein argues that the current system overvalues risk, ignores individual differences, and needlessly deprives patients of valuable treatments.

Documents from R&D, clinical affairs, regulatory, and sales and marketing can be in the millions. Throw electronic information into the mix, and the number of documents required for litigation increases exponentially.

To one major legal scholar, drug safety regulation isn't just about meeting standards, it's about what you take away from one group of patients in order to benefit the rest.

Even when NICE has said that drugs should be available to anyone who needs them, patients still have to convince their Primary Care Trusts.

Peter Rost, former Pfizer executive turned whistleblower, isn't just at war with his old employer. He's crusading against all of pharma, an industry he likens to the mob.

Long turnaround on ad reviews adds new complications to the process of developing marketing plans.

When one company purchases another's branded trademarks as keyword search terms, the goal is to lure consumers to the buyer's site.

The Deficit Reduction Act was designed to save the government money on Medicaid. But it also has the potential to change the very way pharma companies conduct business-if they can just figure it out.

The US Department of Justice thinks that "Average Wholesale Price" should mean just what the words say-no more, no less. Why? It's never meant that before.

MSLs tend to stay put. Just three in 10 left a job after less than a year. Half held their current position for more than three years.

Scientists are worried about what they can and cannot say. Senior scientists feel that if they voice the disagreements that are important to scientific discussion, they might have to leave FDA.