Author Archive

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 »

Woodcock Cites a “Turning Point” in Drug Development

Erik Greb PharmTech editor

Some drugmakers have blamed what they see as a slow and overly cautious FDA for the industry’s weak pipelines. Last week, I cited drug-approval figures to show that the agency was not standing in the way of innovation. A closer look at the figures contradicts another part of the critics’ argument—the industry’s pipelines may not be so weak after all. Read more »

Weak Pipelines? Don’t Blame FDA.

Erik Greb PharmTech editorFacility rationalizations, outsourcing, and staff reductions can provide only so much of a cushion to pharmaceutical and biopharmaceutical manufacturers about to drop off the patent cliff. The ideal way to remain profitable is to discover and develop innovative new drugs, but this task has proven increasingly difficult for drugmakers over the past few years. Jonathan Leff, a managing director at venture-capital firm Warburg Pincus, says that FDA is partly to blame. Read more »

BIO’s Prescriptions for FDA

Erik Greb PharmTech editorIt’s not hard to find employees at large- or small-molecule drug companies who have gripes about FDA. On and off the record, people have complained that the agency’s review process is slow and that its decisions can be erratic. Perhaps hoping to make a positive contribution to this discussion, the Biotechnology Industry Organization (BIO) made several proposals last week for improving FDA’s operations. Read more »

Protection for Generics Companies, But Not Patients

Erik Greb PharmTech editorIn a decision handed down late last week, the US Supreme Court gave manufacturers of generic drugs significant legal protection from liability. In Pliva v. Mensing, the Court ruled that patients cannot sue these companies under state law for failing to warn them about the risks associated with their drugs. Although generic-drug firms may welcome the decision, I think it has unpalatable implications. Read more »

Is Biotech Following in Big Pharma’s Footsteps?

Erik Greb PharmTech editorBiologics are still the hot commodity in the drug industry. Observers call large-molecule drugs the therapies of the future, and these medicines’ complexity makes them difficult for would-be follow-on manufacturers to create. Big Pharma companies that have not yet acquired biopharmaceuticals firms are considering doing so to bolster their pipelines and profits. But not all biologics companies are living large, as data from Ernst & Young remind us. Read more »

Bayer and “the Fairer Sex”

Erik Greb PharmTech editorHaven’t we heard this story before? Bayer HealthCare Pharmaceuticals faces a class action suit alleging that it discriminates against its female employees. In late May, the class bringing the suit expanded to include female sales representatives and all women in the company’s Consumer Care unit. The employees’ complaint alleges that Bayer is hostile toward women, pays them less than it pays men, and retaliates against women who object to these conditions. Read more »

Diligence Is Our Due

Erik Greb PharmTech editorIn 2010, the US House of Representatives’s Committee on Oversight and Government Reform held two hearings after scandalous cGMP violations at McNeil’s Puerto Rico facilities came to light. Former FDA Deputy Commissioner Joshua Sharfstein told the Committee that the agency would review McNeil’s plan for correcting deficiencies to ensure that the corrective actions were effective. “FDA intends to keep a close eye on these facilities until the company earns our confidence back,” said Sharfstein. 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 »

Big Pharma, We Hardly Knew Ye

Erik Greb PharmTech editorBig Pharma’s sales forecast is not likely to improve anytime soon. Consulting firm Bain and Company predicts that the top 25 drug companies’ annual sales growth will be no more than 1% through 2016. To compensate for reduced revenue, investors are urging manufacturers to cut expenses that do not add value. One such expense, in many investors’ eyes, is research and development (R&D). Read more »

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