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2013 Oncology Practice Roundtable

This past week or so, with Obamacare’s start up less than a year away, we have been treated to several entertaining vignettes as the nation’s governors begin to wrestle with the realities of the new healthcare law.

At CBI’s 10th Annual Pharmaceutical Compliance Congress, Maame Ewusi-Mensah Frimpong, deputy assistant attorney general, consumer protection branch, civil division, at the US Department of Justice, said being compliant means understanding people, and their motivations.

The Office of Health Economics (OHE) has released a new study examining drug development costs over the past 30 years.

Monday, February 4, is World Cancer Day. Eli Lilly & Co., one of big Pharma’s biggest, has decided to give the moment its due with the launch of a new policy advocacy initiative to ensure that patients actually benefit from the flood of new oncology treatments now emerging from the industry’s research labs.

The much-discussed US v. Caronia case, which has raised questions about the Food and Drug Administration prosecution of pharma companies for making off-label product claims, doesn’t change very much, according to FDA’s top drug marketing enforcer.

2012 was a record year for patent settlements between branded pharma and generics companies.

In the dog-eat-dog world of federal deficit reduction, there seems to be one health-related spending cut with broad bi-partisan support: require drug companies to give the federal government “a better deal on medications for low-income people on Medicare.”

A new international agreement to reduce mercury contamination of air and water was recently adopted by 140 countries, without a proposal that threatened to limit access to vaccines in much of the world.

Biopharmaceutical companies are touting their huge investment in R&D, which has filled the drug pipeline with more potential first-in-class medicines, including orphan drugs, personalized medicines and new therapies based on novel scientific strategies.

By 2018, the amount health insurers spend per person on specialty, or biologic drugs, will equal or surpass the amount spent on traditional products, according to a new report.

Over the last few years I’ve worked with pharma marketers trying to preach and teach the virtues of digital channels. It has been a thankless task, with bucket loads of blood, sweat, and tears of frustration.

Global consultancy Cegedim has released its latest survey on how and where big Pharma puts its promotional dollar.

A survey of 600 patient groups worldwide conducted in late 2012 revealed that perceptions of the pharmaceutical industry soured in the past year, mainly due to issues of access, pricing, patient safety and transparency.

The Tufts Center for the Study of Drug Development (CSDD) sees two key trends as increasingly important for pharmaceutical companies to maintain success:

On average, cancer docs in the US would much rather deal with pharma sales reps in person as opposed to online, and drug companies are hiring more reps to support a slew of newly approved oncologic drugs.

The perennial fat got chewed during the first two days at J.P. Morgan’s annual healthcare conference – buy back stock or raise dividends? – and the usual suspects lurked, but newcomers like Walgreens and not-so-pharma companies like Life Technologies packed the presentation halls and corridors,

30 years ago last week, the US Orphan Drug Act came into being, and with it, a door of possibilities opened up for patients with literally thousands of untreated diseases.

Thankfully, the civil war is not a public relations issue for Big Pharma, but the long-term business implications for the Middle East region are cagey.

2013 may be a number associated with the fate of the luckless, but our annual review of the business and policy environment for Big Pharma suggests otherwise-as we near the midway point in the "tween" decade, there is good fortune in store for those with the perspective that comes with the long view.

Industry Forecast 2013, The Search for Safe Harbors

The Securities and Exchange Commission filed charges on Eli Lilly and Co. yesterday for violations of the Foreign Corrupt Practices Act (FCPA) that allege the drug maker’s subsidiaries overseas bribed foreign officials in Russia, China, Brazil and Poland.

At the end of last month, the European Medicines Agency approved its budget and work program for the coming year, promising to implement measures to increase operational efficiency, enhance transparency and communication with stakeholders, and improve the quality and consistency of rulemaking.

A just-published report from the European taskforce trying to help Greece crawl out of its crisis makes clear just how significant a role health reform is supposed to play in restoring health to the economy.

With the general election behind us, the anticipated avalanche of ObamaCare regulations has begun. Last week, it was reported that more than 13,000 pages of rules and regulations have been issued by HHS since Nov. 6th

Hindsight can be a great teacher – but only if you have the self-awareness needed to adapt those learnings to the next business challenge, whose rough edges are by definition almost always “non-recurring.”