Shutdown Forces FDA, HHS No-Shows

Officials from FDA and the National Institutes of Health (NIH) were scheduled to explain developments in clinical trial registration and transparency at the Drug Information Association’s conference on Clinical Trial Disclosure in Bethesda, Md. this week. They sent in slides, and one HHS official even pre-recorded his presentation. But the government shutdown kept them from showing up in person.

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Taking Drugs off the Short List

Erik Greb PharmTech editorDrug shortages are increasing at an alarming rate. Between 2005 and 2010, the number of drug shortages per year leapt from 61 to 178. This year’s total, 220 as of October, already surpasses that of last year. Fortunately, FDA has taken a step that is intended to prevent drug shortages from becoming crises. Read more »

Tax Breaks for Big Pharma: A Remedy for Unemployment?

Erik Greb PharmTech editorWorried about our persistently high rate of unemployment (and his bid for re-election), President Obama is urging Congress to pass portions of his jobs bill. In addition to aiding the economy, creating jobs could help reduce the number of people who are forgoing medications, which would be a boon for the pharmaceutical industry. Perhaps with this in mind, the Association of Clinical Research Organizations (ACRO) has thrown its weight behind a bill it says would create American jobs.

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Drugmakers, Uncle Sam Wants You to Help Reduce Spending

Erik Greb PharmTech editor

It’s crunch time on Capitol Hill. Before Congress will consider raising the debt ceiling by next week’s deadline, they have insisted on achieving a budget deal that will reduce the federal debt over the long term. Tensions have mounted as President Obama and leading lawmakers have taken turns grandstanding and negotiating. Both parties agree that spending cuts should be part of the budget deal, and some Democrats have expressed willingness to find opportunities for savings in Medicare and Medicaid. But these programs might now be spending less money if one bill on the Senate’s calendar had passed when it was originally introduced. Read more »

Will Senator Kohl Thwart Drugmakers’ Strategy for Survival?

Erik Greb PharmTech editorMakers of small-molecule drugs are in treacherous waters. The Scylla of generic-drug competition rears on the horizon, ready to bite into innovators’ profits. At the same time, companies’ research-and-development productivity seems to have been sucked down into Charybdis. How will drugmakers survive these perils? Read more »

The Executioner’s Drug

Erik Greb PharmTech editorAt a press conference in the waning days of 2010, Senator Amy Klobuchar (D-MN) raised an alarm about what she called an “unprecedented” drug shortage. Citing a scarcity of treatments for chemotherapy, she called for greater collaboration between industry and FDA to ensure that Americans have access to the medicines they need. But shortages also can affect drugs that are used for purposes other than healing. Read more »

Women’s Victory at Novartis—and Setback in the Senate

Erik Greb PharmTech editorAt the end of a week that saw several major companies announce job cuts, the pharmaceutical workforce finally got some good news on Friday. Manhattan US District Judge Colleen McMahon said that she expected to approve an agreement between Novartis Pharmaceuticals (Basel) and a class of 6200 women, thus settling a gender-discrimination lawsuit. “It is the rare settlement where economic damages are compensated in full,” the judge said, according to an article in the Wall Street Journal. Read more »

Is PhRMA Credible about the R&D Tax Credit?

Erik Greb PharmTech editorRecently, the US Senate voted against a bill that would have made permanent the research and development (R&D) tax credit, thus dealing a blow to one of the pharmaceutical industry’s legislative priorities. The Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization have been agitating for Congress to make the R&D tax credit permanent. They argue that it would promote job growth. We certainly need it, but would the tax credit achieve this goal? Recent history seems to indicate otherwise. Read more »

Protection from Patent Dependence

Erik Greb PharmTech editorIn the current economic slump, generic versions of branded drugs have become a bigger thorn in innovators’ sides than before. To safeguard their profits for just a bit longer, many companies have paid generic-drug manufacturers to delay the introduction of their products to the market. US and European authorities have called these arrangements anticompetitive, though, and events on Capitol Hill last week indicate that they might not be tolerated much longer. Read more »

Gearing Up for Another Round in Healthcare Reform

Patricia Van Arnum PharmTech editor The US Senate’s vote this past weekend to proceed with debate on a legislative proposal for healthcare reform portends—what by all accounts—promises to be yet another rigorous round of policy and political opinion. A Google search for the past week alone shows that almost 500,000 blogs (459,049 at the time of posting of this blog) have been posted in response to the Senate’s action to move forward with considering healthcare reform. In the swirl of this public opinion, where does the pharmaceutical industry stand? Read more »

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