Category:

Three people injected with an unauthorized herpes vaccine by a Southern Illinois University researcher have filed suit against his company, demanding compensation for alleged adverse side effects from the experiments...SIU professor William Halford, who died in June, had injected Americans with his experimental herpes vaccine...in 2016 and 2013 without safety oversight that is routinely performed by the FDA or an institutional review board...The lawsuit, which was filed Friday in an Illinois circuit court, demands compensation from Halford’s company, Rational Vaccines, alleging his research violated U.S. and international laws aimed at protecting the rights of participants in experiments…Rational Vaccines has said it considers the 2016 trial a success—though it is unclear what data it used to support that claim...SIU has...acknowledged that Halford’s conduct violated university rules and U.S. laws but said that Halford hid his misconduct from the university.

The US Food and Drug Administration released the Standardization of Data and Documentation Practices for Product Tracing – guidance last week, which elaborates on industry standards relating to the Drug Supply Chain Security Act...(which) aims to build an electronic system to trace prescription medicines in the US...The move to fully electronic traceability information is a positive step in terms of data integrity, availability and exchange in the supply chain...It is important firms within the pharmaceutical supply chain move in the same direction and embrace the advantages of technology and digitisation... Moving to a completely electronic system should only bring advantages to CMOs and the wider industry, improving data integrity and security and reducing the time and resource needed to produce and exchange traceability...

With more than 700 orphan designation requests last year, the Food and Drug Administration...announced a new pilot program to make the request process more efficient...The pilot will include a new form intended to make the submission process easier for sponsors to complete orphan designation requests, and to make the process more efficient for FDA...FDA also released an on-line tutorial to guide sponsors through the submission process and Gottlieb noted there is a new inter-center consult process to streamline and standardize communications...In addition to the pilot, FDA vowed to eliminate the orphan drug designation backlog, and is planning a public meeting to discuss the scientific and regulatory issues related to cancer treatments that target a tumor’s genetic features rather than its location in the body...“We’ll also consider the appropriate application of orphan incentives to this new paradigm of drug development, and how we apply designations to these indications,”...

Drug-toting travelers now have a place to trash their stash before boarding a flight at McCarran International Airport...Green metal bins have popped up at the nation’s eighth-busiest airport, creating a safe space for airline passengers to dispose of marijuana before boarding a flight...Even though recreational marijuana is legal in Nevada, the drug is banned inside Clark County’s network of airports and security checkpoints operated by the Transportation Security Administration...About 20 “amnesty boxes” were installed over the past week outside high-traffic areas of McCarran, Henderson Executive and North Las Vegas airports, bearing a sign citing the local law that prohibits pot within airport property...The move comes after Clark County’s Board of Commissioners banned marijuana possession and advertising on airport property as a way to comply with existing federal laws...

When Celgene Corp. revealed receipt of a Refusal-to-File letter for its blockbuster hopeful multiple sclerosis drug ozanimod, shares in the big biotech dropped as much as 10%...The decline is no surprise — such a major disclosure was bound to hit Celgene's stock price because the Food and Drug Administration's decision not to accept the New Drug Application will significantly impact the time when (and if) ozanimod ever gets to market, potentially costing Celgene hundreds of millions in future sales...But not all pharmas seem to be so upfront with shareholders about the letters from the FDA, according to a BioPharma Dive analysis...Public disclosure therefore falls to the company when it receives one of these rejections. Company executives can disclose as much or as little information about the letters as they deem appropriate...There has been controversy over the issue for years related to CRLs (Complete Response Letters) — and public and investor outcry for the FDA to publish the letters...it comes down to what is "material" to investors, something defined by the Securities and Exchange Commission but which also gives companies some latitude...

State governments have stepped up their oversight of drug compounding in recent years, yet resource limitations may be hamstringing regulators from even more thorough inspections of traditional pharmacies, according to a new report...In 2015, the District of Columbia and 26 states required routine inspections of compounding pharmacies at least once a year. But by 2017, the number had fallen to 22 states plus the nation's capital...Many states have taken significant steps to better regulate drug compounding since the disastrous meningitis outbreak that came as a result of the New England Compounding Center's adulterated steroids...32 state boards of pharmacy require traditional pharmacies that compound sterile drugs to be in complete alignment with quality standards set forth in the U.S. Pharmaceutical Convention General Chapter. Another 11 states have provisions in place that they've determined are as strong — if not stronger — as the General Chapter's guidance...Issues have arisen despite that progress...Pew's research identified more than 50 reported or potential compounding errors from 2001 to 2017. The errors were linked to 1,227 adverse events, including 99 deaths — and those figures are likely low estimates, according to the organization.

It’s been nearly two months since a law requiring doctors to take additional steps before writing prescriptions for opioids went into effect, though some of the questions and concerns raised by doctors about the law are only now just starting to be answered...A subcommittee formed specifically to address concerns related to the implementation of the law grappled with some of the areas of uncertainty at a recent meeting with the goal of ultimately clarifying the exact steps doctors must take when writing a prescription for painkillers and figuring out what punishment they should face should they fail to do so. But to what extent that clarification can or should be codified into state regulations will be up to the Board of Pharmacy, which will discuss the matter at a meeting early next month...Though the law, AB474, applies to any prescriber of opioids — from advanced practice registered nurses to dentists — most of the concerns about the law have come from medical doctors, who have lamented the extra time obtaining an informed consent and making a “good faith effort” to obtain a patient’s medical records. Some have even said they won’t write any more prescriptions for painkillers in response to the law and will direct patients instead to pain doctors...The Board of Medical Examiners is responsible for creating any disciplinary regulations they deem appropriate, but the law leaves any other clarifying regulations up to the Board of Pharmacy.

The Federal government...unveiled two initiatives designed to improve patients' access and control over their personal electronic medical records, and also pledged to overhaul Meaningful Use and refocus on data interoperability and ease of use among providers...Under the MyHealthEData initiative, patients will have access to their complete electronic health record, which they can take from doctor to doctor, choose the provider they want, and give that provider secure access to their data, leading to greater competition and reducing costs, the Centers for Medicare & Medicaid Services said...Under a second initiative, Medicare has launched Blue Button 2.0, which allows traditional Medicare beneficiaries to access and share personal health data in a universal digital format, and connect claims data to the secure applications, providers, and services they trust...CMS Administrator Seema Verma unveiled the initiatives...at the annual conference of the Healthcare Information and Management Systems Society...CMS is also taking an aggressive stance against data blocking...it is the priority of this administration to ensure that every patient and their doctor can receive free and timely access to their electronic data,"...

A Georgia pediatric cardiologist pleaded guilty...wrongfully disclosing information about his young patients to an Aegerion Pharmaceuticals Inc sales representative seeking to identify potential new users of an expensive cholesterol drug...Dr. Eduardo Montana...entered his plea in federal court...Montana pleaded guilty to a misdemeanor charge that he wrongfully disclosed patients’ individual identifiable health information. While he faces up to a year in prison, prosecutors have agreed to recommend a term of probation...According to prosecutors, after Aegerion in 2012 received regulatory approval to market Juxtapid for treating high cholesterol in adults with a rare genetic disease, the drugmaker promoted it for use by patients who lacked the condition...Montana...also disclosed information to a senior Aegerion executive promoting Juxtapid’s off-label uses and provided the sales representative the code to access his electronic medical record system...

The generics sector has been looking to M&A as a way to combat the pricing pressure crushing top lines around the industry. But that strategy just got a whole lot less attractive...The Federal Trade Commission has suggested it will take steps that could force buyers to hold onto drugs they don't want, a shift that may even be holding up one big deal already...It’s not uncommon that when generics companies combine, the acquirer winds up with two versions of a complex drug—one on the market, and one still in development. In the past, a divestment of the pipeline candidate has solved the issue...Bruce Hoffman, acting director of the FTC’s Bureau of Competition, said earlier this month that the body will no longer allow companies to jettison complex drugs that are still in the works...That’s not a good development for wannabe buyers, as on-the-market drugs are much more valuable than prospects that may or may not ever see any sales. The move “has potential to change valuations and add risk to generic deals in the future,”...