- Agencies target ‘illegal, unapproved’ products that claim to treat opioid addiction (washingtonpost.com)
Federal regulators said Wednesday that they are cracking down on marketers and distributors selling a dozen products that “illegally” claimed to treat or cure opioid addiction and withdrawal...In letters sent earlier this month, the Food and Drug Administration and the Federal Trade Commission cited products that target people desperate to find relief from their addictions. They include “Opiate Freedom 5-Pack,” “CalmSupport” and “Soothedrawal.” Most of the 12 items are marketed as dietary supplements, while two are homeopathic remedies, the FDA said...The letters are the latest effort to combat what FDA Commissioner Scott Gottlieb called a “proliferation” of unapproved products claiming to treat opioid addiction. In a statement, Gottlieb excoriated “unscrupulous vendors who are trying to capitalize on the epidemic by taking advantage of consumers and selling products with baseless claims.”
- Lawmakers weigh measure to fight high drug prices (thehill.com)
Lawmakers are considering adding a measure aimed at fighting high drug prices to an upcoming spending deal, in what would be a rare defeat for the powerful pharmaceutical industry...The measure, known as the Creating and Restoring Equal Access to Equivalent Samples Act, is intended to prevent branded drug companies from using tactics to delay competition from cheaper generic drugs...Pharmaceutical companies are pushing back and lobbying against the measure, arguing it would harm patient safety and open companies up to wasteful lawsuits...But they might not be successful in their effort. Lobbyists and congressional sources say the measure could be added to a long-term government funding bill as a way to help pay for higher budget caps. The measure is estimated to save more than $3 billion...The measure would allow a generic company to develop its own safety protocol for a drug rather than have to develop a shared protocol with the branded company. Supporters of the bill say there would still be rigorous standards in place to ensure safety...The bill would also allow generic drug makers to sue to obtain the samples they need. Powaleny warned the bill would lead to “wasteful litigation between companies.”
- FDA Moving to Enhance Drug Approval Transparency, Gottlieb Says (ptcommunity.com)
New pilot program to evaluate disclosure of clinical study reports...As part of its efforts to enhance transparency around drug approval decisions, the FDA is exploring ways it can continue to build on its obligation to share information…The agency is especially focused on information that can improve patient care and better inform providers about the products they prescribe. One place where it is evaluating how it can release information that may better inform scientists, providers, and patients is clinical study reports (CSRs)...The FDA has launched a pilot program to evaluate whether disclosing certain information included within CSRs following approval of an NDA improves public access to drug approval information...The FDA intends to post the parts of the CSRs that were most important to the agency’s assessment of the safety and efficacy of the drug, specifically, the study report body, the protocol and amendments, and the statistical analysis plan for each of the participating product’s pivotal studies...
- FDA Delays Implementing Parts of ‘Intended Use’ Rule (raps.org)
Confusion and concerns over portions of a tobacco-related final rule have pushed the US Food and Drug Administration to delay implementation of the sections dealing with the types of evidence FDA may consider to determine how a manufacturer intends for its medical product to be used...This is a determination that can have significant implications for, among other things, how manufacturers communicate about and promote their products. How we determine intended use is an important issue that touches many fundamental aspects of the FDA’s work...FDA is seeking comments on the proposal to delay...effective date of the portion of the rule related to intended use of medical products, though the tobacco-related portions of the final rule will go into effect...At issue is how the initially proposed rule sought to remove a sentence, which FDA Law Blog last February called "the famous 'knowledge' sentence: 'But if a manufacturer knows, or has knowledge of facts that would give him notice, that a [drug or device] introduced into interstate commerce...is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a drug/device which accords with such other uses to which the article is to be put.'"...But the final rule did not remove the sentence and instead amended it with new language that angered industry groups, which called the move "a new and unsupported legal standard."
- Follow the Money: Democrats see fewer contributions from Big Pharma in 2017 (thenevadaindependent.com)
The pharmaceutical industry largely snubbed Democrats when it came to doling out campaign contributions last year after the Democrat-controlled Legislature passed a bill to increase drug-pricing transparency in June...Only four Democrats — two members of Assembly leadership and the chairs of the Assembly and Senate health committees — received any contributions from the industry last year while 19 received industry contributions in 2016. By contrast, 19 Republican lawmakers and candidates and four Republican PACs or committees received donations from pharmaceutical companies in 2017, roughly comparable to 2016 trends...The $17,000 in pharmaceutical donations Democrats received represented about 1 percent of the more than $1.4 million the industry spent in Nevada in 2017. Republicans received 67 percent of the industry’s contributions, while the remaining 32 percent went toward funding the industry’s opposition, through the Healthy Nevada PAC, to the insulin pricing transparency bill sponsored by Democratic Sen. Yvanna Cancela in 2017.
TOP 10 PHARMA MONEY RECIPIENTS:
- Republican State Leadership Committee: $914,000
- Attorney General candidate Wes Duncan: $8,500
- Assembly Speaker Jason Frierson: $8,250
- Sen. Ben Kieckhefer: $6,500 (including $1,250 to his PAC)
- Sen. Joe Hardy: $6,250 (including $1,250 to his PAC)
- Assemblyman James Oscarson: $5,000
- Gubernatorial candidate and Attorney General Adam Laxalt: $3,500
- Assemblyman Mike Sprinkle, 2017 chair of the Assembly health committee: $3,250
- Assemblyman Chris Edwards: $3,000
- Assembly Minority Leader Jim Wheeler: $2,850
- Hospitals eye making generics for 20 drugs that they say are overpriced or in short supply (cnbc.com)
Several hundred hospitals that plan to form their own generic drug company are eyeing making "about 20" pharmaceutical products whose existing versions either cost too much or are in short supply for no good reason...Dr. Marc Harrison, chief of...Intermountain Healthcare, during an interview on CNBC's "Closing Bell," would not identify the existing drugs that the new company wants to replicate on its own, or have done on a contract basis..."We think it will be early '19 before our first drugs come to market."...the group also is hoping to possibly get additional financing from "philanthropists who are sick of this activity" by drug companies that is "creating shortages and driving prices in an irrational fashion."...Intermountain is leading the collaboration with several other large hospital groups, Ascension, SSM Health and Trinity Health, in consultation with the U.S. Department of Veterans Affairs, to form a not-for-profit drug company. The groups together represent more than 450 U.S. hospitals.
- U.S. court invalidates patent on J&J cancer drug Zytiga (reuters.com)
A U.S. administrative court...invalidated a Johnson & Johnson patent on its blockbuster prostate cancer drug Zytiga, bringing rivals closer to selling generic versions...The Patent Trial and Appeal Board said a Johnson & Johnson patent describing a method of administering Zytiga should not have been granted because the process it described was obvious...The ruling was a victory for U.S. generic drug company Argentum Pharmaceuticals LLC, which had asked the board to invalidate the patent in hopes of bringing its own version to market...The patent is due to expire in 2027. Argentum and other generic drug makers have been blocked from launching their own versions of the cancer drug until its expiration date...Zytiga generated nearly $2.3 billion in sales for Johnson & Johnson in 2016.
- Generic-Drug Firms Fall as U.S. Threatens to Sue for Damages (bloomberg.com)
Shares of generic-drug makers including Mylan NV and Teva Pharmaceutical Industries Ltd. fell after the Justice Department’s antitrust division said it might sue them for damages in a price-fixing probe...If taxpayers were overcharged because drugmakers conspired to raise the price of drugs, the Justice Department will consider suing to seek damages, Makan Delrahim, the division’s chief, said...“To the extent that taxpayers have had to pay that bill, I think the taxpayers should recover,” he said. “We will get involved on the civil side and recover damages for the U.S. government.”...Mylan dropped as much as 3.1 percent after the comments and traded down 0.6 percent to $46.25 at 1:37 p.m. in New York. Teva’s U.S. depositary receipts dropped as much as 2.8 percent and were down 1.5 percent to $20.41 and Endo International Plc fell 5.6 percent to $6.92...The three drugmakers are among more than a dozen companies targeted by the Justice Department and state attorneys general in a multi-year investigation into generic drug price-fixing. So far, the probe has led to guilty pleas from two former executives of Heritage Pharmaceuticals...
- FDA issues warning letter to Australian CMO (fiercepharma.com)
The warning letter was sent late last month to Delta Laboratories of New South Wales, Australia, after the FDA put all of the company’s human and animal drugs and antibiotics on its import alerts list in September...According to the FDA, Delta didn’t fully investigate discrepancies, including signs that might have indicated microbial contamination and didn’t have the processes needed to assure products would remain stable during storage and through the expiration date. It also noted the quality assurance unit didn’t have the necessary authority to make sure those kinds of standards are met...Senior management stated that your firm has struggled with manufacturing this drug product, and that you were still conducting research to gain better product and process understanding. Although you acknowledged a lack of understanding to assure consistent quality, you still commercially distributed drug products to consumers...The agency strongly recommended that Delta hire a consultant if intends to continue to producing products for the U.S.
- Wal-Mart launches program to safely dispose of unused opioids (reuters.com)
Wal-Mart Stores Inc...will provide customers filling prescriptions for opioids with a packet of powder that will help them dispose of leftover medication in order to help curb misuse and abuse...The company said patients filling any new class II opioid prescriptions at its pharmacies will receive a free packet of the product - called DisposeRx - when filling a new prescription. Patients with chronic Class II opioid prescriptions will be offered a free packet every six months...In order to safely dispose of opioids, patients would add warm water and the DisposeRx powder to their pill bottle, which then forms a biodegradable gel around the pills.