- Teladoc-owned BetterHelp to pay $7.8M to online therapy users for alleged data misuse, per FTC order (fiercehealthcare.com)
The Federal Trade Commission has reached a settlement with online therapy company BetterHelp...over allegations that it shared consumers’ health data with companies like Facebook and Snapchat for advertising purposes...BetterHelp is banned from sharing consumers’ health data, including sensitive information about mental health challenges, with third parties for marketing and ad targeting...BetterHelp also agreed to pay $7.8 million to consumers to settle charges that it revealed consumers’ sensitive data with third parties for advertising after promising to keep such data private...READ MORE
- Rite Aid Says It’s Halfway Home On Store Transfers To Walgreens (forbes.com)
Rite Aid...has now transferred 1,114 stores to Walgreens Boots Alliance as part of a larger deal with the nation’s largest pharmacy chain...In all, Walgreens will over the next few weeks buy 1,932 stores and three distribution centers from Rite Aid for nearly $4.4 billion in cash. Rite Aid...has received “cash proceeds of $2.424 billion, which the company continues to use to reduce debt.”...Before agreeing in September to buy 1,932 Rite Aids, Walgreens had been trying to buy all of Rite Aid before antitrust scrutiny from the Federal Trade Commission that ultimately led to the deal’s undoing...As a smaller pharmacy chain, Rite Aid is focusing on eight states largely on the East and West Coats with plans to invest heavily in its pharmacy benefit manager EnvisionRx, which works with employers and government health programs like Medicare to better control drug costs. PBMs are the middlemen between drug makers and patients when it comes to buying prescription drugs and getting discounts for their customers.
- Walgreens, Rite Aid end $9.4 billion merger (pharmacist.com)
Walgreens Boots Alliance and Rite Aid have called off their $9.4 billion merger agreement. Instead, Walgreens says it will attempt to purchase one-half of Rite Aid's stores for $5.18 billion in cash. Executives said they crafted the smaller deal to address regulatory issues, but antitrust experts said it does not eliminate competition concerns. The Federal Trade Commission's review of the original Walgreens-Rite Aid transaction stretched 18 months, and the commission reportedly did not back away from concerns that the deal would have harmed competition. The commission worried about the merger's impact in regions where both companies have a strong store presence...Walgreens...said the smaller transaction addresses "all substantive" FTC concerns. The company will be adding stores in regions where it currently lacks a large presence, including the Northeast and MidAtlantic..."There's a chance that it won't go, that's the reality of the process. We believe it makes sense, we just have to wait until it plays out."
- Mylan CEO accepts full responsibility for EpiPen price hikes, but offers little explanation (statnews.com)
...Mylan Pharmaceuticals CEO Heather Bresch accepted "full responsibility"...for the price hikes that caused national outrage..."If EpiPen had to be the catalyst to show what hardworking families are facing, it will have been worth it," she said...referring to the upfront costs that many people encounter with high-deductible health plans. Mylan increased the price of an EpiPen two-pack nearly 550 percent to $608 over the past decade...Bresch reiterated remarks she made...at a congressional hearing...citing a lack of transparency in the pharmaceutical pricing system for the controversy surrounding the product. She justified the price increases by pointing to what she insisted were "investments" made to improve the device and patient access...the company has made plans to sell its own authorized generic version of EpiPen at roughly half the price. And...agreed to a $465 million settlement with the Department of Justice for shortchanging Medicaid over rebates...Meanwhile, the Federal Trade Commission was asked by various lawmakers to investigate whether Mylan violated antitrust laws because the contract for one option in the discounted school program, at one time, contained a clause forbidding school districts to buy rival products...
- FDA names drugmakers potentially acting to delay cheap generics (reuters.com)
The U.S. Food and Drug Administration...listed a number of drugmakers it said could be improperly blocking access to their medicines in order to delay generic competition...But many of the companies immediately pushed back, saying the FDA list of drugmakers may be out of date and that some of the drugs included on it already have generic competitors...The FDA said the list contained all of the inquiries about drugs it had received from generic drugmakers since 2005. It said companies generally do not inform it if they have made samples available after a generic developer has reached out to the agency...The agency said companies on the list may be using FDA safety regulations and other tactics to deny access to their medicines from generic drugmakers hoping to copy them...The FDA is notifying the Federal Trade Commission, which can investigate anti-competitive acts, of cases where drugmakers may be blocking access to their products if there is no safety reason...
- 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.”
- FTC accuses Shire subsidiary of delaying generic rivals (biopharmadive.com)
The Federal Trade Commission...accused a Shire plc subsidiary of filing dozens of "sham" petitions with the Food and Drug Administration in an effort to delay generic competition to its branded prescription drug Vancocin HCI...the FTC alleged that Shire ViroPharma filed 43 citizen petitions with the FDA (along with 3 lawsuits) over a seven-year period, knowing that the FDA typically waited to approve generic drugs until it had resolved any outstanding citizen petitions...a deliberate attempt to maintain a monopoly...ViroPharma’s efforts led consumers and other purchasers to pay hundreds of millions of dollars more for the drug.
- New FTC rules hurt M&A prospects for hard-hit generics players (fiercepharma.com)
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,”...
- FDA Expands Generic Drug Priority Reviews (raps.org)
Talk of bringing down the price of pharmaceuticals often hinges on generic competition, and the US is seeing approvals of new generic drugs faster and more consistently than ever – a trend likely to continue...The progress comes as Food and Drug Administration Commissioner Scott Gottlieb...indicated that the agency will expand which abbreviated new drug applications will see priority reviews..."Earlier this year we made changes to how we prioritize the agency’s generic drug submissions. The goal was to prioritize the review of generic applications until the FDA has approved three generic versions of each particular drug," Gottlieb said in a statement. "Today we’re expanding this competition-focused policy to prioritize any application that can meet the FDA’s approval standards at the point when the 180-day exclusivity period expires on a first generic entrant to a branded medicine."...The shift could accelerate generic competitors to market more quickly and help bring down costs, and comes a day after the Federal Trade Commission held a workshop on drug competition.
- Collins, McCaskill Release Committee Report of Bipartisan Drug Pricing Investigation (aging.senate.gov)Senator Susan Collins...Chairman... of the Senate Aging Committee, released a report on drug pricing...titled, “Sudden Price Spikes in Off-Patent Prescription Drugs: The Monopoly Business Model that Harms Patients, Taxpayers, and the U.S. Health Care System.” The comprehensive report details the findings stemming from the Committee’s bipartisan investigation into abrupt and dramatic price increases for prescription drugs whose patents expired long ago. Through close examination of the monopoly business model used by four pharmaceutical companies to exploit market failures, the report examines how companies acquired decades-old, off-patent, and previously affordable drugs and then raised the prices suddenly and astronomically at the expense of patients. The report provides case studies of the four companies; explores the influence of investors; assesses the impacts of price hikes on patients, payers, providers, hospitals, and the government; and discusses potential policy responses.
- Enact the Increasing Competition in Pharmaceuticals Act...to incentivize competition to address regulatory uncertainty, small market size, and other factors that serve as limitations to generic entry;
- Encourage generic competition by ensuring the right to obtain samples and simplifying Risk Evaluation and Mitigation Strategies;
- Consider allowing highly targeted, temporary prescription drug importation to provide prompt price relief for major price increases in off-patent drugs;
- Take steps to prevent the misuse of patient assistance programs and copay coupons;
- Reinvigorate the Federal Trade Commission to take greater enforcement action on drug company mergers, operations, and drug market dynamics; and
- Improve transparency in the health care system.