PharmExec Blog

Nothing is Rotten in the State of Denmark

By Julian Upton | Published: March 2, 2010

EU-flag2Guest blog by Reflector, Pharm Exec Europe’s Brussels correspondent.

Denmark is still on the fringes of some European Union policies. Notably, it has not yet embraced the euro as a currency, and it keeps its distance from the common defence policy. But in one respect, its pharmaceutical industry has just shown that it is well abreast — and even ahead — of EU developments.

As from the start of this year, the members of its national drug industry association, LIF, have committed themselves to a new code of practice on lobbying. The code sets ethical standards for member companies’ dialogue and negotiation with authorities and politicians. Read More »

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US and Europe At Risk from Substandard Medicines

By Julian Upton | Published: February 25, 2010

Guest blog by Helen Disney, Chief Executive and Founder of the Stockholm Network, a pan-European think tank.

helen

Helen Disney

When most of us look at taking a new medicine we tend to think it will make us better. Some of us may think about possible side effects but few of us expect the medicines we take to actually be dangerous. Recently, the public and policymakers have become more aware of the issue of counterfeit medicines — especially as patients increasingly learn about how to shop safely online for pharmaceuticals. But scant attention has been paid to a safety issue that is also important to patients — the problem of substandard medicines.

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Posted in Biotech, Emerging Markets, Europe, Global, Guest Blog, Regulatory, Safety | Tagged , , , , , , , , , , , | Leave a comment

Merck, Lilly, Pfizer: One for All and All for One

By Oriana Schwindt | Published: February 24, 2010

Just a month after Andrew Witty’s announcement that GSK will make more than 13,500 of its malaria compounds available to all, Pfizer, Merck, and Eli Lilly have thrown their do-gooder hats into the ring as well.

Together, the three drug giants will pull together an undisclosed dollar amount in seed funding and create the independent, non-profit Asia Cancer Research Group (ACRG). The new company’s purpose is to grab Asia’s lung and gastric cancer problem by the horns.

Neil Gibson, chief scientific officer of Pfizer’s oncology research unit, pointed out that there’s a “huge unmet need and a disproportionate health burden to Asian patients.” A significant portion of lung cancer in Asia seems to be related to a mutation in a gene that helps regulate cell growth and division—a mutation far more common in Asia than the West. Gastric cancer shares this skew, accounting for 630,000 deaths each year.

The ACRG will have a six-person research-specific board (two experts from each company) to approve major decisions and material. Lilly will provide virtual access through its research site in Singapore. Researchers can cull from at least 2,000 tissue samples as part of the ACRG’s two-year plan to create the biggest pharmacogenomic cancer database in the world. While research avenues into other cancers are a possibility in the future, the group’s focus for now is on lung and gastric cancer.

This is just the latest example of a pharma “open source” policy, a concept adopted by the techies long ago. Open-sourcing takes some of the pressure off R&D units, which have sustained heavy losses the last couple quarters.

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FDA and GSK on the Hunt for Stolen Drugs

By George Koroneos | Published: February 24, 2010
Burglar + Bag
Image by Johnny Grim via Flickr

We typically don’t get emails from FDA  asking for information about stolen goods with massive bold letters, but that’s what just came into our inbox. Looks like a transport truck containing a mix of GlaxoSmithKline’s pharmaceutical and over-the-counter medications was jacked in Puerto Rico on January 29, and the feds are looking to the general public for any information. It’s curious that it took more than three weeks to announce the news. No word on whether the theft was just now discovered, or if they are reaching out to us because all other leads have run dry.

Below is a list of the stolen drugs. Please contact 1-800-551-3989 if you have any information about this incident.

NDC     Description     Lot #   Quantity

(Unit of Sale)
0173-0697-00    Advair Diskus 500/50mcg 60 Dose 9ZP2144 2
0007-5500-40    Albenza 200mg 112s      9B001   4
0007-3152-13    Avandaryl 4mg/2mg 30s   9ZP2540 48
0029-3159-00    Avandia 4mg 90s 9ZP2237 48
0029-1527-22    Bactroban Cream 15gm    C433259 160
0007-4139-20    Coreg 3.125 100s        MTSR1212        4
0007-3370-13    Coreg CR 10mg 30s       9ZP4771 96
0007-3371-13    Coreg CR 20mg 30s       9ZP0413 95
0007-3372-13    Coreg CR 40mg 30s       9ZP3661 224
0007-3373-13    Coreg CR 80mg 30s       9ZP3920 16
0173-0201-55    Daraprim 25mg 100s      A44519  3
0173-0470-01    Epivir 150mg 60s        9F004   3
0173-0470-01    Epivir 150mg 60s        9K007   9
0173-0662-00    Epivir HBV 100mg 60s    9D003   1
0173-0471-00    Epivir Oral 10mg/ml 240ml       9E003   12
0173-0719-20    Flovent HFA 110mcg 120 Actuation        F0638   48
58160-825-51    Havrix 720 ELU Tip Lok 10s      AHAVB371BA      1
0173-0260-35    Lanoxin Inj 0.5mg/2ml 50s       8M920   2
0173-0713-25    Myleran 2mg 50s 809980  1
0007-4883-13    Requip XL 6mg 30s       9ZP3419 2
0173-0750-00    Treximet 85mg/500mg 9s  8ZP2362 60

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Obama Reveals Healthcare Reform Plan

By Jill Wechsler | Published: February 22, 2010
Barack Obama delivers a speech at the Universi...
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The health reform proposal unveiled by the White House on Feb. 22, 2010 retains a number of provisions that directly affect drug coverage and industry revenues. The plan highlights that it will close the Medicare drug benefit “doughnut hole” by 2020 to make drugs more affordable to the elderly. Seniors will get some relief this year through a $250 rebate, and coinsurance will phase down over the next decade.

Because broader insurance coverage and gap closure will expand drug sales and industry revenue, the Obama plan also increases a proposed “assessment” on pharma from $23 billion in the Senate bill to $33 billion, starting in 2011 to avoid tax problems. Medical device makers also would have to pay $20 billion in fees over 10 years, starting in 2013.

Similar to previously approved Senate and House bills, the plan retains a boost in Medicaid drug rebates from 15 to 23 percent and authorizes discounts on drugs sold to community hospitals. Drug companies would have to fully disclose financial arrangements with doctors, and pharmacy benefit managers would report rebates and discounts on drugs, along with success in boosting generic drug use.

The proposal also seeks to curb “pay-for-delay” deals between brand and generic drug manufacturers; stipulates that effectiveness research would not influence coverage decisions; and supports establishing a pathway for follow-on biologics.

For these and most of the provisions in the White House announcement, there are few specifics or proposals for implementation.

Many key provisions in enacted Democratic legislation are featured in the plan: an insurance exchange to provide coverage options to the uninsured; tax credits to help individuals and small business pay premiums; curbs on insurance industry discriminatory practices; aid to state Medicaid programs; an individual coverage mandate (with low penalties); and cuts in rates for Medicare Advantage plans.

Most notable politically, there’s no govern-run coverage option. And the plan significantly scales back a proposed tax on high-cost “Cadillac” health plans, making up the lost revenue with a tax hike on high-income individuals. Most notable politically, there’s no govern-run coverage option.

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Posted in News, Regulatory | Tagged , , , , , | 2 Comments