According to a Food and Drug Administration (FDA) official, the U.S. health regulators are missing target dates to act on new drug applications because the agency doesn´t have enough staff to handle them after getting new duties from Congress a year ago. Opposing views and reactions to news on FDA delays. Further details.

In October 2007, Genentech informed that it would no longer provide cancer drug Avastin to compounding pharmacies, which broke-up the drug into smaller portions for use in patients with age-related macular degeneration. The reason given by the drugmaker was that the FDA had concerns over some batches that did not meet standards for use in the eye. A recent FDA letter to Senate investigators seems to call into question Genentech's reasons

The trade groups for drug and medical device makers announced their support for public disclosure of payments, gifts, honoraria and travel reimbursements given to doctors, thereby “increasing transparency” the way drugs are marketed in the U.S., said a congressman.

In a letter sent to top pharma chief executives, namely to Merck & Co, Pfizer, J&J, and Schering-Plough CEOs, Reps. John Dingell and Bart Stupak urged drugmakers to curb drug ads, and to voluntary place a hold on drug ads until after 2 years the product hits the market. In addition, lawmakers exhort pharma companies not to market products until certain clinical studies are completed

Actor Dennis Quaid urged the U.S. Congress to preserve patient’s rights to sue drugmakers to avoid turning consumers into "uninformed and uncompensated lab rats." Quaid´s campaign was prompted by a near-fatal drug mix-up in which his newborn twins were administered 1,000 times the correct dose of Baxter´s anticoagulant Heparin

A revised Senate bill would demand drugmakers and medical device makers to publicly report gifts, incentives, and “other business courtesies” extended to doctors over $500 a year and not over $25, as a previous version had required. The new language was endorsed by Eli Lilly and lawmakers expect other companies to follow suit. Critics have been carping on about the industry’s common practice of providing lavish perks to doctors for promotional purposes, claiming they underhandedly influence prescribing habits

No new or different conclusions were the results of the Congressional hearing on Pifzer Inc., Merck & Co. Inc., Schering-Plough Corp. and Johnson & Johnson’s direct-to-consumer ads reviewed by the lawmakers this week – all parties continued to stick to their stances, although there was mention of possible congressional action from Democrat Party representatives to seek tighter controls on TV ads. Further details.

A U.S. congressional panel will examine television commercials for cholesterol drugs Lipitor (Pfizer) and Vytorin (Schering-Plough/Merck), and for anemia drug Procrit (J&J) at a hearing on whether such advertisements are deceptive or misleading.

Baxter CEO Robert Parkinson will testify before U.S. lawmakers this week in their probe of tainted Heparin batches which may have led to at least 81 deaths linked to low blood pressure or allergic reactions after patients were given the contaminated blood thinner made from pig cartilage coming from China. Lawmakers lash out at the FDA on foreign drug oversight

Members of a U.S. Congressional sub-committee and Food and Drug Administration (FDA) Commissioner Andrew von Eschenbach discussed the issue of inspections of foreign drug manufacturers at a hearing, and lawmakers called on the FDA to do more to help ensure the safety of drug imports. The panel´s oversight subcommittee, chaired by Rep. Bart Stupak, continues to be concerned with this issue since January 2007, after the Baxter heparin case in which 81 people died following allergic reactions. The FDA did not inspect Baxter´s Chinese supplier before approval. Further details.

Two U.S. Democrats stated their investigation had raised questions about how Merck & Co Inc and Schering-Plough Corp documented a key meeting about a controversial study of their Vytorin cholesterol drug, noting that company documents showed minutes from a key meeting were “created after the fact.” Further details.

Iowa Republican Senator Charles Grassley wants Amgen Inc to explain why some doctors received higher rebates on purchases of the drugmaker’s anti-anemia drug Aranesp, amid increasing scrutiny by FDA officials and U.S. lawmakers of marketing of ESAs after studies found patients given higher doses died sooner. Full details

Johnson & Johnson and Amgen Inc. have been sent letters by a U.S. congressional committee requesting them records related to the promotion of their anemia drugs. The lawmakers are questioning the companies’ advertisements or promotional offers, suggesting these may have contributed to excessive off-label use of the drugs. Further details.

The Senate Finance committee, investigating whether Merck and partner Schering-Plough, makers of cholesterol drug Vytorin, withheld data that would hurt sales, released new evidence supporting such suspicions. Drugmakers were accused of withholding negative results to boost sales

Top U.S. medical device companies face scrutiny as a U.S. Senate committee probes perks given to doctors from medical device makers aimed at creating loyalty for products like artificial hips and knees. Companies will disclose gifts on the Internet

The leader of a congressional panel investigating the Food and Drug Administration (FDA) has said FDA Commissioner Andrew von Eschenbach should resign his post. Two government panels are investigating the health regulating agency due to its alleged failure to fulfill its role in the current cases of antibiotic ketek – it had been proven the Aventis antibiotic had fraudulent clinical trials yet was approved by the FDA - and blood-thinner heparin, a Baxter medication one of which’s active ingredients is manufactured in laboratories never inspected by the FDA. The heparin case broke on February 12th, after a possible link of the blood thinner with four deaths and some 350 patients reporting allergic reactions. Full story.