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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.”

Teva is eager to start moving in the right direction after a particularly rocky 2016. Problem is, it’s still paying for pay-for-delay decisions made by its products’ previous owners...the generics giant last week agreed to a $225 million settlement with a group that picked up Bayer antibiotic Cipro...Also...the FTC refiled charges against Watson and former parent Actavis, claiming they illegally blocked a lower-cost generic version of Endo’s Lidoderm after entering into a pay-for-delay pact with Endo...All things considered, “the cumulative sum of fines is getting noticeable”—especially for “cash-strapped” Teva...The Israeli company earlier this month walked down its previously outlined 2017 guidance by more than $1 billion after new 2016 launches didn’t hit their marks. And some analysts think Teva’s new revenue forecast—a range of $23.8 billion to $24.5 billion--may still be too high...

Mylan has been in the hot seat since reports of its extravagant price hikes for the EpiPen, a device which millions of Americans, including 1 in 13 children, rely on as a life-saving backstop, emerged last month...Now, the company has agreed to hand over documents to indignant lawmakers seeking to probe its pricing practices...Several members of Congress have been demanding more information from the generic drug giant about its pricing practices since the EpiPen scandal broke. Some, including Minnesota Sen. Amy Klobuchar, have even called for Federal Trade Commission investigations into the company...The U.S. House Committee on Oversight and Government Reform specifically asked for more detailed information about Mylan’s pricing habits, including discounts given to patients, at the end of August...That information is expected to reach lawmakers by the end of the week...

Mylan has cleared another hurdle in its ongoing attempt to acquire Perrigo, announcing Tuesday that the Federal Trade Commission had given the deal its OK, as long as Mylan divests itself of some products following the acquisition’s completion. With the completion of this step — and the recent U.S. court decision not to issue an injunction on behalf of Perrigo against Mylan — all Mylan needs is word from Perrigo’s shareholders on whether or not they will accept the company’s $27 billion acquisition offer…

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."

The Federal Trade Commission just cracked down on an unusual product that has long enjoyed exemption from regulation: homeopathic drugs. Available everywhere...homeopathic products are advertised as an effective way to treat a wide range of conditions...Americans spend over $3 billion a year on homeopathy, and the market appears to be growing steadily...companies selling these products have never been required to show they are effective at doing what they claim...the FTC announced its “enforcement policy statement” about homeopathic product labeling...the recommendations are pretty minimal...the agency produced a report that concluded customers were likely to be deceived by labels that did not carry the appropriate disclaimers, and therefore disclaimers stating that these products are untested will now be required. The requirement is not technically a law like…The rules require packaging to effectively communicate two key disclaimers:

•     “There is no scientific evidence that the product works.”
•     “The product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.”

The Federal Trade Commission said...it sued drugmaker Endo International PLC, alleging the company violated federal antitrust laws by paying hundreds of millions of dollars to delay generic competition against two of its biggest drugs...The suit...is the latest by the FTC to target alleged "pay-for-delay" agreements. In these deals, generic-drug companies typically agree to drop patent challenges against brand-name drugs and to refrain from launching cheaper knockoffs before a certain date in exchange for payments from the manufacturer of the brand-name drugs...The FTC contends such agreements cost consumers and taxpayers $3.5 billion annually by keeping drug prices higher than they would be otherwise...Suits like the one filed against Endo are relatively rare...These are very resource-intensive cases, and we don’t have the resources to bring that many cases," Markus Meier, FTC acting director for the bureau of competition...

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.

A US senator is urging the US Federal Trade Commission to accelerate its antitrust investigation into a drug maker that sells Suboxone (buprenorphine/naloxone), a medicine used to treat addiction to opioids and narcotics...The appeal by Senator Edward Markey comes less than a week after 35 states filed an antitrust lawsuit against Indivior (Reckitt Benckiser), accusing the company of engaging in a scheme to block generic competition. In doing so, the company "drove up prices and deprived states and consumers of lower costs," Markey wrote in his letter on Tuesday to FTC…Reckitt raised the price of its pill while lowering the price of the newer film version. And the patent on the new version does not expire until 2023. This is a pharmaceutical industry tactic known as forced switching, since patients and physicians have little choice but to consider a newer, higher-priced version...Markey also pointed out that the manufacturer has "significantly impeded the FTC investigation by attempting to deny the FTC access to thousands of pages of documents that are integral to the investigation." However, he also noted that the federal court overseeing the matter later ordered the company to produce the documents...So will the FTC step on the gas?

Pfizer Inc and Allergan Plc said they have received a request for additional information from the U.S. Federal Trade Commission with respect to their merger...The FTC's request for information extends the waiting period required under antitrust rules to 30 days, after the companies have provided the information...The companies said the request was anticipated as part of the regulatory process and they were working with the FTC in connection with the review.