Regulatory

R&D is surging, but new methods and data raise new manufacturing and regulatory challenges.

At time when people can't even get a 3 percent cost-of-living increase, how can pharma justify price hikes pushing 500 percent (in some categories). A new study by the government's General Accountability Office examines why drug products took a massive price leap in recent years.

The push for government transparency continues with Phase I of FDA's plan to expose the inner workings of that secretive cabal known as the Food and Drug Association. First up, fancy new FAQs.

Sanofi-Aventis is recalling hundreds of thousands of doses of the childrens' version of its H1N1 vaccine. Conspiracy theorists are going to have a field day.

Painkiller abuse has become so prevalent that FDA is working with pharma to create a strategy for handling misuse of all drugs across the entire opioid category.

Drug manufacturers came under fire at a hearing of the House Energy and Commerce?s health subcommittee for bumping drug prices 10 percent this year. Pharma claims rumors that it?s boosting costs in anticipation of healthcare reform are baseless, but the industry could be facing an uphill battle.

They already dominate the pharmaceutical market, and now generics are poised to move into biologics and complex dosage forms.

FDA and Congress weigh policies for improving drug safety via ads and written information.

The US oversight arm scripted a hefty report complaining that FDA is not moving fast enough when it comes to screening clinical trials data for drugs green lit through its expedited approval program.

All the focus on drug safety raises concerns about FDA delays in approving new drugs for market.

Collins seeks to parlay genomic discoveries into new biomedical therapies. Comparative effectiveness research, he says, should identify subpopulation responses to treatment and support personalized medicine.

Pain medications containing propoxyphene could lead to overdose and death, according to new labeling mandated by FDA. However, public requests to take these drugs (including Darvon and Darvocet) off the market have been denied.

Feds claim results of study comparing car crash deaths and children on ADHD drugs were not paramount to pulling kids off of ADHD treatments.

The Word Health Organization just bumped the H1N1 influenza to pandemic alert phase 6 (the highest alert level), making it the first worldwide pandemic in 41 years.

The feds green lit a task force charged with easing the flow of communication between FDA, pharma companies, and the general public. While the team is being billed as a task force for transparency, it?s still unclear what is being revealed.

You know those loud soundtracks and distracting visuals during the safety information in your TV ads? Critics have been complaining about them, and new draft guidance from FDA is calling them a "no-no."

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.

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

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:

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.