Washington Drug Letter

Most who are following the user fee bills pending in Congress expect lawmakers to combine the Generic Drug User Fee Act (GDUFA) with legislation to address the escalating problem of drug shortages.

Drugmakers could see dramatic changes to Medicaid rebates under a proposed rule that would base these payments on the actual price pharmacies pay for therapies, instead of an estimated acquisition cost.

Drugmakers could see a stronger crackdown on off-label promotion according to a new Office of Inspector General (OIG) report that directs HHS to focus on the practice.

Ben Venue subsidiary Bedford Laboratories is voluntarily recalling one lot of its overdose drug acetylcysteine solution USP after finding a single glass particle in a 30 mL vial, the FDA says.

The FDA has issued three long-awaited biosimilars guidance documents, recommending a stepwise approach to showing biosimilarity that could allow eased trial requirements if a sponsor can demonstrate biosimilarity in earlier steps.

The FDA has decided not to extend exemptions from labeling requirements to products in all federal, state and local drug stockpiles, the agency states in a final rule.

A federal judge has sided with the FDA, ruling it was correct in approving Sandoz’s generic version of Sanofi’s blockbuster blood-thinner Lovenox.

An FDA advisory panel voted 12–1 Wednesday that Amgen’s Xgeva did not demonstrate a favorable risk-benefit profile in castrate-resistant prostate cancer patients (CRPC) at high risk for metastasis — a blow to Amgen’s sBLA prospects for earlier use of the drug in a preventative setting.

Saying the company was blindsided by the agency, drug distributor Cardinal Health has blocked an effort by the Drug Enforcement Administration (DEA) to suspend its Florida operations after four pharmacies it serves allegedly filled an inordinately high number of painkiller prescriptions.

The FDA has handed ViroPharma a complete response letter (CRL) on its industrial scale manufacturing supplement for hereditary angioedema (HAE) drug Cinryze, citing concerns about a portion of the cleaning validation.

The FDA is training a cadre of investigators to inspect positron emission tomography (PET) drug plants, and applicants with multiple sites can expect to see the FDA at all of their facilities.

Money is at the center of a drug industry dispute on proposed changes to the accelerated approval process — a debate that has created a schism between large drugmakers and their smaller counterparts, an expert says.

Marketing applications for drugs in short supply could see expedited review under the Drug Shortage Prevention Act introduced in the House Jan. 31.

The FDA will decide on Genentech’s metastatic breast cancer drug pertuzumab by June 8 after granting the experimental drug priority review.

The FDA’s Oncologic Drugs Advisory Committee (ODAC) advised against approval of Eisai’s sNDA for cancer drug Dacogen, saying clinical data and post-hoc analyses did not show robust efficacy or improved performance over existing standards of care.

A new bill intended to spur drugmaker interest in developing drugs for chronic illnesses may prompt creation of a distinct approval process for such treatments, congressional aides say.