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...Gilead Sciences told investors...that an unbranded campaign encouraging baby boomers to get tested for hepatitis C helped boost screening and diagnosis numbers, which in turn upped sales of its HCV therapies...The drugmaker markets several blockbuster HCV therapies, including Sovaldi and Harvoni. It most recently received FDA approval for Vosevi…About nine million people underwent testing for hepatitis C in 2016, up 15% compared to 2015's testing rates...This led to about 190,000 new diagnoses in 2016, a 32% increase compared to 2015...Gilead's unbranded campaign targeting baby boomers launched in October...We always feel that part of our role in the areas...that we operate is to provide education...Gilead reported that its HCV franchise generated sales of $1.9 billion in the second quarter of 2017, down 17% from the same quarter in 2016. But sales increased over the first quarter of the year, driven partly by patient starts...

The scarcity of a simple medicine is complicating treatment for patients...Chronic drug shortages have burdened U.S. medical care for several years. Studies have estimated drug shortages add more than $400 million in annual U.S. health-care costs because hospitals and doctors are forced to seek more expensive alternatives, and health-care workers must spend extra time managing shortages...The shortages of low-cost medicines have been caused by a decline in the number of suppliers for certain products and failures by companies to build enough production capacity or meet manufacturing-quality standards...also...thinner profit margins for many older drugs reduce incentives for companies to invest in them...As a result of the shortage, doctors and hospitals are resorting to riskier and sometimes costlier treatments...FDA...said the agency works closely with manufacturers of drugs in short supply to help restore stocks, and asks other companies to increase production if they manufacture the same drug. The FDA says such efforts has helped cut the number of new shortages but can’t prevent all of them...

The FDA needs to clarify its standards for showing a biosimilar drug is interchangeable with the original biologic and how the biosimilar should be named and labeled, commenters said in response to an agency draft guidance...The Food and Drug Administration draft...described how an applicant can establish that a biosimilar, a highly similar, less expensive version of an FDA-approved biologic drug, can be substituted for the biologic on which it is based without a physician’s approval…If you’re a biosimilar applicant, you’re happy the FDA has provided the guidance, but you think it’s asking for too much information...If you’re the owner of the patent for the original biologic, you strongly support the need for the switching studies the FDA requires in order to show that switching from the original biologic to the biosimilar is safe. If you’re an organization that represents patients, you want assurances the interchangeable biosimilar is safe and effective for each condition for which the original biologic is approved...

Secretary of Health and Human Services...Tom Price is continuing to push the Senate to further increase the industry fees paid to the US Food and Drug Administration...which would upend the agreed-to amounts negotiated by FDA and industry for the next five years, and allow for further cuts to the agency’s congressional appropriations...the Senate Health, Education, Labor & Pensions committee advanced a bill reauthorizing the user fee programs for prescription drug, medical device, generic drug and biosimilar industries without the additional fees that President Donald Trump requested in his budget blueprint for the next fiscal year...The fees included in the bill were what both sides negotiated for PDUFA VI, MDUFA IV, GDUFA II and BsUFA II...Price wrote in a letter...to Sen. Patty Murray, the ranking member of the HELP committee: "To ensure the FDA has the critical resources needed to keep pace with this field, the President's Budget Blueprint proposes to increase and restructure the medical product user fee programs at FDA to be 100 percent user fee supported programs, with no funding triggers that require budget authority financing."...

Generic drug makers are turning to M&A to shield themselves against a concerted effort by U.S. regulators to crack down on steep drug prices...Impax Laboratories Inc, Perrigo Company Plc and Alvogen Inc have been talking to advisers about strategic options for their generics businesses, ranging from acquisitions to increase scale to an outright sale of the units...Mallinckrodt Plc, one of the largest producers of the generic opioid painkiller oxycodone, has been exploring a sale of its specialty generics unit…To bring down prices, the Food and Drug Administration has committed to eliminating the backlog of drug applications awaiting its approval. This could mean nearly 4,000 new medicines will come onto the market over the next several years, based on FDA estimates of drugs awaiting approval...Even before a potential flood of new products, small and mid-sized drug makers were under pressure as consolidation among generic drug distributors has made it less profitable for them to sell their drugs...A merger or a sale to a rival could alleviate some of the pressure through cost-cutting, reduced competition and new markets and products. It could also help companies negotiate better terms with drug distributors...

Endo International Plc agreed...to remove its long-acting opioid painkiller from the U.S. market to comply with the health regulator's request last month, sending its shares down as much as 3 percent...The U.S. Food and Drug Administration in June had requested the withdrawal of Endo's Opana ER, marking the first time the agency asked for an opioid painkiller to be taken off the market for public health reasons...The regulator's request followed the recommendation of an independent panel of advisers, which concluded that the drug's benefits no longer outweighed its risks...

It’s taken five months, but the FDA has finally issued its first untitled letter of the year for promotional infractions. The agency's promotional watchdogs scolded Orexigen Therapeutics for alleged infractions in a TV commercial for weight loss drug Contrave...the Office of Prescription Drug Promotion says the television ad misleads viewers by touting Contrave's benefits and downplaying its risks. For instance, the letter says the spot omits important risk information—including potential neuropsychiatric reactions, such as suicidal thoughts, that are highlighted in a black-box label warning...By omitting serious risks associated with Contrave, the TV ad misleadingly suggests that Contrave is safer than has been demonstrated...Orexigen is currently addressing the OPDP guidance...

Trump vs. Big Pharma: Can He Bring Drug Prices Down?...U.S. Food and Drug Administration Commissioner Scott Gottlieb spoke with Bloomberg News about drug pricing, new medicine and regulations. This transcript of the interview has been edited for clarity and length.

• What’s the FDA’s role to play in drug pricing and what can the agency do, given that it hasn’t traditionally had a mandate to address the issue?
• Is it just small, opportunistic drug companies that are "gaming" the system, or is this something bigger companies do as well?
• What about the rest of the administration? Trump talked a lot about drug pricing on the campaign trail and after, yet we haven’t seen much action other than yours.
• What about an executive order on drug pricing -- there was talk that Trump was going to come out with something. Is that still being worked on?
• What about drugs like EpiPen, would you come out with new rules there to create more competition? [EpiPen, made by Mylan NV, is what’s known as a drug-device combination, where both the medicine and the device that administers it can have patent protections.
• But is it reasonable to assume you’re looking at doing something like this, on these types of devices?
• One of the things we’ve seen from the administration is, get rid of regulation, get rid of regulation, get rid of regulation. How does your philosophy as a regulator –- one of the biggest regulators in the U.S. government –- how does that line up with what the Trump administration has called for?
• Some of the things you’re doing to create more competition among drugs, people could interpret as a loosening of standards. I wonder if you think that’s the case?
• Through the years we’ve seen the agency go through cycles, of pushing drugs out into the market faster, versus being much more conservative about safety. Is the balance at the FDA changing?
• How broadly can you apply new standards or guidelines for drug approval? There’s been talk about it in cancer, but what about other diseases?

...the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse...The FDA’s decision is based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy). This decision follows a March 2017 FDA advisory committee meeting where a group of independent experts voted 18-8 that the benefits of reformulated Opana ER no longer outweigh its risks...

Should drugs that win FDA approval on an accelerated path—often without strong evidence of efficacy—command the same high prices as products that undergo the full menu of agency scrutiny?...Not necessarily, two doctors contend in a new journal article. And they have some ideas for bringing the costs of those drugs way down, at least until their makers can prove they really work...Accelerated approval is a problem because it forces Medicare and Medicaid to pay for drugs that can cost hundreds of thousands of dollars and yet may not work for many patients...private insurers may decline to cover those drugs, denying patients access to products that were supposed to get to them faster...The FDA requires drugmakers who gain accelerated approval to perform post-marketing studies to prove efficacy—and therein lies an opportunity for the healthcare system to save money...(authors) propose. They suggest drug manufacturers be required to discount products until confirmatory trials are complete, or that a portion of the full price they’re charging be held in escrow until the results of the trials are available...We see the value in getting products that qualify for accelerated approval to market for patients, but we believe the price paid by taxpayers should reflect the strength of the available evidence about the drug’s clinical impact...