- FDA criminal office draws fire from agents and doctors over drug import crackdown (reuters.com)
The FDA’s Office of Criminal Investigations has spent thousands of hours pursuing foreign-imported, mislabeled drugs. But more than half of all OCI cases end without charges, and critics contend the agency’s efforts protect drug makers as much as consumers...On April 5, 2012, a criminal investigator from the Food and Drug Administration named Robert West charged into an oncology clinic...West was chasing a lead that Dr. Anindya Sen...purchased an unapproved...cancer drug Avastin...Without a warrant or permission, he and an FBI agent rifled through cabinets, seizing drugs that appeared to have foreign, non-FDA approved packaging…A...judge later said West’s...statement about the drugs being counterfeit "apparently was not the truth." West’s search was declared illegal, and the evidence was deemed inadmissible…Prosecutors are declining to pursue many FDA cases, citing a lack of prosecutorial merit, criminal intent or strong evidence, Reuters found in a review of more than 170 letters detailing why the Department of Justice declined cases. The letters, obtained under the Freedom of Information Act, appear to bolster critics’ claims of agency overreaching…
- This is how 3-D bioprinting companies are transforming drug development (medcitynews.com)
... cells generally like having company, forming communities with other cell types to make complete tissues. However, quite often, researchers isolate cells from their 3-D environments, creating 2-D models that don’t always replicate complex biology...But now, an entire industry is emerging to recapitulate various tissues more realistically. 3-D bioprinting has the capacity to layer different cell types, creating more biologically accurate liver, kidney, skin and even tumor tissues. The hope is that more lifelike tissues will produce better scientific results...Organovo is the leader in 3-D bioprinting...The...company has been selling 3-D liver tissue to pharma companies for about 18 months and is about to expand into kidney tissue. The goal is to support drug development by using these 3-D models to gauge toxicity...Kidney and liver toxicology studies are required for every product before it goes into humans....The high costs of clinical trials could eventually make this a go-to technology for pharma and biotech, providing better data to spot toxicity early and avoid costly mistakes…
- Report: 3 tips for pharma to provide beyond-the-pill services (mmm-online.com)
Physicians expect pharmaceutical companies to provide more beyond-the-pill services, as they face increasing pressure from empowered patients as well as accountable care organizations and integrated delivery networks...The report...found that 46% of the physicians it surveyed expect drugmakers to provide beyond-the-pill services, and 34% have used a beyond-the-pill service from a pharma company...Here are three key insights for pharma marketers to take note of:
- Drugmakers should provide more than just product information on their websites.
- Physicians are more likely to prescribe a product if it comes with beyond-the-pill services.
- Sales reps should be leveraged to engage physicians.
- What do patients know about generic biotech drugs? (reuters.com)
Many patients haven’t heard of "biosimilars," generic versions of complex biotech drugs, and even some who say they’re familiar with these medicines may still be confused about them, a small European survey suggests...To see what patients know about biosimilars, researchers analyzed data from online surveys completed by 1,181 patients with irritable bowel disease or Crohn’s disease, chronic intestinal problems that are increasingly treated with biosimilars...just 38 percent (383) of the survey respondents had heard of biosimilars...researchers asked...more questions to see what they knew about these medicines, 47 percent said they worried about whether the copies were safe and 40 percent said they had concerns about whether the generics were effective…The study by Dr. Laurent Peyrin-Biroulet...found most patients were more concerned about the safety and effectiveness of biosimilars than whether they were a lower-priced alternative to brand name biotech drugs...the findings highlight the need for more patient education about biosimilars...
- Kroger May Be a Buyer for Walgreens, Rite Aid Stores (thestreet.com)
Shares of Kroger were lower Wednesday. The supermarket chain has emerged as a buyer for stores of Rite Aid. The drugstore chain is close to being acquired by Walgreens Boots Alliance, but Rite Aid would have to sell off overlapping assets in order to appease regulators. Kroger looks to be the potential buyer for all of Rite-Aid's overlapping stores considering that it is well capitalized and has experience running pharmacies in its stores.
- Making drug formulary search tools better for patients (catalyst.phrma.org)
There is a real need for patients to have information about out-of-pocket costs and clinical tools being used when it comes to their coverage. A new prescription drug search tool that includes information about cost sharing, prior authorization and step therapy will be available to residents of Washington, D.C., shopping for coverage during the upcoming open enrollment period. These types of tools are important for patients, enabling them to find the best health care plan to meet their needs...DC Health Link’s new offering will allow patients in D.C. purchasing private health insurance to input up to 10 prescriptions and see which plans cover their drugs and the cost sharing that goes with them...The new DC Health Link tool also improves transparency and information about deductibles. One feature allows people to clearly see plan details, including whether available plans have a separate drug deductible, whether a medication is subject to a copayment or coinsurance and copayment amounts and coinsurance percentages...While progress continues to make marketplace websites more consumer friendly, additional improvements are still necessary to ensure consumers have a clear understanding of the choices in front of them when picking a health plan...
- Drug Industry Group Starts Ad Campaign to Defend Pricing (bloomberg.com)Innovation Saves - Biotechnology Innovation Organization (youtube.com)
A top pharmaceutical lobbying group is launching an ad campaign to defend drugmakers that have been under fire for their pricing practices..."We’re under pressure and scrutiny like never before," said Jim Greenwood, chief executive officer of the Biotechnology Innovation Organization. The campaign, called "Innovation Saves," says new drugs can save both lives and costs to the health-care system...BIO is trying to reshape perceptions after a year of finger-pointing among insurers, drugmakers and health-care providers about why the medical system is so expensive..."This campaign is about defending the indefensible: astronomical price increases, drug pricing gimmicks, and massive cost increases," Clare Krusing, a spokeswoman for America’s Health Insurance Plans, said in a statement. "The way that the pharmaceutical industry can show real innovation is by embracing solutions that make treatments and cures affordable to every patient."...
- Why the Walgreens/Prime Deal Could Transform the PBM Industry (drugchannels.net)
...Walgreens Boots Alliance and Prime Therapeutics rolled out a highly innovative partnership. It could have wide-ranging implications...This novel union aligns a pharmacy benefit manager, retail pharmacy chain, and health plans via joint ownership of a new mail and specialty pharmacy company. If executed properly, it will be a best-of-breed business model that could reshape the PBM and pharmacy industries. For manufacturers, organized customer management just got even more complicated...The new business could also pose a serious challenge to pure-play PBMs that lack a health insurer partner or an economically-aligned retail dispensing channel…
- FDA slams drug maker for touting unapproved leukemia treatment to docs (statnews.com)
Celator Pharmaceuticals proudly displayed a large poster touting its experimental Vyxeos (CPX-351) medication as an effective salve for treating acute myeloid leukemia. The poster was, in fact, one of countless placards featured prominently on the exhibit floor at the American Society of Clinical Oncology meeting…the Celator poster managed to stick out...Vyxeos has not yet been approved to treat AML...Celator reported positive clinical trial results for the drug...But that’s not the same thing as having clearance to market a product. Unfortunately, that’s the impression regulators had after looking at the poster…As far as the Food and Drug Administration is concerned, Celator was, effectively, promoting a drug that was misbranded. And so the FDA sent the company (now Jazz Pharmaceuticals)...a letter to complain about its promotional behavior...From a public health perspective, these claims and presentations are concerning because they include representations in a promotional context regarding the safety and efficacy of an investigational new drug that has not been approved by the FDA...
- This Week in Managed Care: September 3, 2016 (ajmc.com)
Justin Gallagher, associate publisher of The American Journal of Managed Care. Welcome to This Week in Managed Care, From the Managed Markets News Network.