Unlike every other country in the world at the time, the U.S. founded its judicial system on the premise “innocent until proven guilty.” Under that guiding principle, the burden of proof – in any enforcement action – lies with the government. That principle has served the nation well for nearly 250 years. But now the FDA is seeking a congressional blessing to change it, under the guise of drug safety. Testifying before a House subcommittee last week, the FDA’s Janet Woodcock noted the stress placed on the agency because it bears the burden of proof when it comes to the...

While 2012 has dawned everywhere else in the world, it’s still 1984 at the FDA. With its Bad Ad program, whistle-blower suits and spotters of conference crimespeak serving as its globalwise eyes and ears, the agency has adopted Big Brother (BB) tactics to promote goodspeak among drugmakers while crimestopping off-label promotion, bringing new life to George Orwell’s newspeak. In the newthink of the FDA, quality of life (QOL) is one of those doubleplusungood phrases that a biotech dare not utter – unless it has conducted a doubleplushuge, FDA-approved, randomized, controlled, double-blind pivotal study, including doubleplusvulnerable populations and diverse subpopulations, to...

An FDA advisory committee this week gave a half-hearted vote of approval – 9-8, with two abstentions – for Alexza Pharmaceuticals Inc.’s Adasuve (Staccato loxapine). But the vote was conditioned on limiting the inhaled antipsychotic to one dose per day and imposing a much stiffer REMS than what the company had proposed. While Alexza didn’t feel that much love from the Psychopharmacologic Drugs Advisory Committee (PDAC), it did get enough to bolster its flailing shares and keep hope alive for FDA approval come the Feb. 4 PDUFA date. A day after the lackluster committee performance, Alexza (NASDAQ:ALXA) hit $1, a...

In last week’s issue of BioWorld Insight, our esteemed Washington editor Mari Serebrov wrote an article titled, “Shorter Exclusivity Could Carry a Hefty Price Tag.” In it, she quoted sources who are very concerned that reducing the current 12-year exclusivity for innovator biologics to seven years, as the president and a number of lawmakers have proposed, would be bad news for patients, payers and drug makers. In the article, Mary Webster, a patent attorney with Nixon Peabody, said: "If you can't corner your market and recoup your costs, are you going to do it?" And suddenly I had a flashback...

By JIM STOMMEN, Medical Device Daily Contributing Writer  The arguments going on these days over the prostate cancer screening test known as prostate-specific antigen (PSA for short) might make one think that there’s something wrong with the test itself. Not so. The argument by what we will refer to as the “anti” side of the issue is with what happens after the routine blood test comes back with a positive finding. Those folks, who go by the name U.S. Preventive Services Task Force, maintain that the PSA test leads to demonstrative levels of over-treatment, doing so to such an extent...

You think the drug shortage is a devil now Just wait around a few years ’Cause you ain’t seen nothin’ yet. When that biosimilar pathway begins to flash Those big green dollar signs, You’ll know, you’ll know, you’ll know, you just ain’t seen nothin’ yet. Those biosimilars will turn your heart away from the old drugs of yesterday. You’ll think you have it comin’, and you’ll want it that way. You’ll say big profits are good profits, so you’ll take what you can get. B-B-B-Baby, you ain’t seen n-n-n-nothin’ yet. Patients will go to the doctor, and he’ll tell them...

Free speech. Most of us take it for granted. Unless you’re a drug company, that is. Since the FDA doesn’t trust biopharma when it comes to drug promotion, the agency believes that, as the watchdog of public health, it’s justified in curtailing drugmakers’ First Amendment rights. The FDA has put teeth to its leash on speech by issuing warning letters, which can block pending drug approvals in the U.S. and abroad. In what it considers more egregious cases, the agency turns speech violations over to the Justice Department to prosecute. As we reported in BioWorld Today, several companies, rather than...

What's causing drug shortages in the U.S., and is it a matter of mechanisms of control or methods of drug production? In 2010, there were shortages of 178 drugs in the U.S., a record-high level. Many drugs on the 2010 list are still unavailable, and the number is growing. It has tripled in the last six years, according to the FDA. Currently there are about 246 drugs in short supply, and that number has risen steadily since 2006. Severe drug shortages are endangering cancer patients, heart attack victims, accident survivors and others. Many people hold the FDA largely responsible for...

As a biotech junkie, I’ll admit I was shocked to the core by Dendreon Corp.’s second-quarter admission that prostate cancer vaccine Provenge (Sipuleucel-T) is thus far not succeeding commercially. (See BioWorld’s news bulletin for details.) The most shocking part? Analyst and investor assumptions that Provenge’s poor performance is due not to reimbursement hurdles, as Dendreon claimed, but to an underlying lack of demand. Doctors and patients don’t want to use the product. Come again? Are you serious? Provenge is the first and only therapeutic cancer vaccine ever to gain FDA approval. I don’t have to tell anyone in the biotech...

Late last month, the American College of Radiology Imaging Network (ACRIN; Philadelphia) along with the National Cancer Institute’s Lung Screening Study Group released the results of the National Lung Screening Trial (NLST). The study supports the idea that CT Screening in older, heavy smokers can reduce mortality rates by 20% compared to standard chest X-rays.  Nearly 53,000 current and heavy smokers between the ages of 55 and 74 at 33 sites across the U.S. were enrolled in NLST. (See full study here) It should be pointed out however that the study results show that CT Screening in these patients turned up a high...