- Nine Explanations For Why The FDA Is Approving Almost Every New Drug Application (forbes.com)The drug development and approval process is about much more than the final “okay” (catalyst.phrma.org)
..Food and Drug Administration, which once approved as few as 40% of new drugs submitted by industry, has been on a green-light-almost-everything jag, approving 89% of drug applications. What’s more, a closer look showed an even higher approval rate. This year so far, 96% of new molecular entities.. – that have been submitted to the FDA have reached the market. For anyone who was watching the FDA a decade ago, that’s just shocking. Good or bad, it’s a radical change...there are a lot of factors that explain why the FDA approval rate is suddenly so high,..
- The approval rate is much lower, because only 12% of drugs that enter clinical trials reach the market.
- Drug companies are better at research, and they are simply producing better drugs.
- Drug companies are picking areas where the chances of approval are higher.
- The FDA is doing a better job communicating with companies.
- The FDA has more power to restrict the use of an approved drug than it used to.
- The FDA is taking a risk by taking strong stands against drug approvals right now.
- The FDA is without a permanent commissioner.
- It’s just random chance.
- In the current political environment, the agency is approving drugs it shouldn’t.
- The FDA blundered badly on the Addyi approval (fiercebiotech.com)The FDA Is Basically Approving Everything. Here's The Data To Prove It (forbes.com)
..in approving Addyi, the FDA has gone overboard, exchanging greater efficiency in favor of purposeful permissiveness…it's lowering its standards on the risk/benefit equation by ignoring the realities of the Internet…agency can't control the viral campaign that's already well under way. It can't control prescribing habits or, more importantly, the demand for this drug. It can't prevent the side effects that we will now be seeing as the drug starts to become available to a much wider population than it's intended for…it's the kind of blunder that could well cost the entire industry if the inevitable backlash causes the FDA to grow overzealous about safety issues…This is a regulatory failure of the worst kind.
- Drugs just don’t get rejected much anymore, report says (fiercebiotech.com)
Picking apart biopharma’s protracted boom,…the vibe that getting drugs approved is simply much easier than it once was…. FDA has been green-lighting new drugs at an escalating rate for the past few years… some think the agency can go farther… 21st Century Cures Act,..contains a bevy of provisions designed to bring medicines to the market more quickly…The bill has faced staunch criticism from public health officials and media outlets, cautioning that there can be too much of a good thing, and improperly evaluated drugs can be just as dangerous to patients as no treatments at all.
- Amgen pays $71 mln to settle Enbrel, Aranesp marketing case (reuters.com)
Amgen Inc has reached a $71 million settlement ...to resolve claims that the biotechnology company promoted its popular Enbrel and Aranesp drugs for uses not approved by the federal Food and Drug Administration… Amgen violated state consumer protection laws by marketing both drugs for off-label uses, through its promotion of Enbrel to treat mild plaque psoriasis and Aranesp to treat anemia caused by cancer.
- Generic Drug Sponsors Will Get Status Reports– But Only For Old ANDAs (pharmamedtechbi.com)
FDA is ready to restore some informal communications for generic drugs, but only for applications not covered by the newly implemented user fee action dates…applicants with pending ANDAs (abbreviated new drug application) that are not covered by user-fee goals will have the right to a status report under a new policy …governing communications with ANDA applicants in response to widespread criticism from the generic industry about the loss of interaction that followed enactment of the Generic Drug User Fee law..
- The Female Libido Pill and Five Other Drugs That Can Be Defeated by Their Own Side Effects (bloomberg.com)
Every medication has risks as well as benefits, and people react to treatment differently. That’s why drug labels are pages long and filled with small print about the possible downsides. Sometimes those side effects actually exacerbate the problem the drug is intended to treat.
- Addyi
- Advair
- Antidepressants
- Osteoporosis Drugs
- Epogen
- MS Drugs
- Valeant Nears $1 Billion Deal for Maker of Women’s Libido Drug (wsj.com)
Valeant Pharmaceuticals International Inc. is nearing a deal to pay $1 billion for the closely held company (Sprout Pharmaceuticals Inc) that just won approval to sell the first drug that aims to boost a woman’s libido,..Valeant would pay all cash, one $500 million installment upfront and one next year,..Valeant would also take on all of Sprout’s 25 employees, including its leadership team, as they complete preparations to begin sales of the drug in October,…
- Is ketamine the best hope for curing major depression? (bloomberg.com)
Food and Drug Administration hasn’t approved ketamine for the treatment of mood disorders, but… studies show that it can quickly alleviate severe depression. There’s no regulation to stop doctors like Brooks from administering ketamine for nonapproved uses—a practice known as "off-label" treatment—"For patients who are suicidal…they can get relief within an hour or two,"…
- Another outbreak from tainted scopes suspected at an L.A.-area hospital (latimes.com)
Huntington Memorial Hospital..it had alerted health authorities about a potential link between patients who have a pseudomonas bacteria and the Olympus Corp. duodenoscopes used to treat them… Federal regulators have attributed this to a design flaw that makes the tip of these instruments hard to clean even when following the manufacturers' guidelines.
- For a Rare Disease, Drug Trials Scramble for Patients (wsj.com)
Companies vie for enrollees amid questions that trials will siphon participants away from each other…After years of effort, scientists and families of young patients with the genetic condition Niemann-Pick Type C are in a position to which any rare-disease community aspires: the prospect of not one, not two, but three companies launching clinical trials to develop therapies…the flurry of commercial interest has sparked an urgent debate. Can the community support more than one trial at the same time?