- Trump FDA Nominee Wants Lower Drug Costs With More Generics (bloomberg.com)Trump selects Scott Gottlieb as FDA nominee (cnn.com)
President Donald Trump’s pick to head the U.S. Food and Drug Administration is among the most vigorous advocates of lowering drug costs by approving cheap generics faster, an initiative aimed directly at the profit centers of major companies...Scott Gottlieb, a former FDA deputy commissioner, would make streamlining approvals his top priority...He’s particularly focused on complex medications that combine old drugs with newer delivery devices, as well as those with unusually complicated formulations...The administration could make the changes without Congress passing a law...But it also risks angering companies that have considerable legal firepower to defend their money-makers...Getting more generics to market faster could save Americans billions of dollars a year...Absent a new law, the FDA could do much to speed approval of generics. It could devise broad guidelines for copies. And the agency could become swifter in approving drug-device combos, finding ways to allow slight differences so long as they wouldn’t confuse patients...
- President’s Pledge
- Complicated Cures
- Pricey Pens
- EpiPen Dispute
- EU recommends suspending hundreds of drugs tested by Indian firm (reuters.com)
Europe's medicines regulator has recommended the suspension of more than 300 generic drug approvals and drug applications due to "unreliable" tests conducted by Indian contract research firm Micro Therapeutic Research Labs...The decision, announced by the European Medicines Agency...is the latest blow for India's drug-testing industry, which has run into a series of problems with international regulators in recent years...The inspections identified several concerns at the company’s sites regarding misrepresentation of study data and deficiencies in documentation and data handling...there is no evidence of harm or lack of effectiveness of the medicines, which include generic versions of many common prescription pharmaceuticals, including blood pressure tablets and painkillers...Drug tests carried out at Indian contract research organizations have been key in getting a huge array of generic medicines approved for sale around the world over many years…In the wake of such trial data scandals, many large drugmakers have been shifting more critical trials back to the United States and Europe over the last three years...
- Biogen staves off patent challenge to blockbuster MS drug (biopharmadive.com)
Biogen's defense of its blockbuster multiple sclerosis treatment Tecfidera (dimethyl fumarate) got a lift...after the U.S. Patent Trial and Appeal Board rejected a patent challenge by a group affiliated with hedge fund manager Kyle Bass...The...Board upheld Biogen's '514 patent on the 480 mg dose of Tecfidera, boosting the chances Biogen will be able to maintain patent protection on the top-selling drug for longer...Despite the positive development, Biogen hasn't fully put to rest the patent challenges surrounding Tecfidera. So-called interference proceedings between the company and Forward Pharma are still ongoing at the Patent Trial and Appeal Board, which could force Biogen to pay Forward royalties on sales of Tecfidera.
- FDA fees for product review would more than double under Trump budget (reuters.com)
The cost to healthcare companies for U.S. regulatory review of their products, including drugs and medical devices, would more than double under the Trump administration's proposed 2018 budget…over $2 billion in fees to be collected by the U.S. Food and Drug Administration from industry, twice as much as in 2017...it also offered measures that would help speed up the approval process for new drugs and other products...The FDA has been charging companies to review their products since 1992. Most of the user fees collected are for prescription drugs - around $866 million estimated in 2017 - and generic drugs - around $324 million...The budget does not say if the fee increases would be evenly spread or directed in a particular area. The budget did not provide specifics on what measures to speed up approvals might include...
- FDA approvals for specialty drugs to pick up in 2017 (managedhealthcareexecutive.modernmedicine.com)
The specialty drugs market is seeing increased competition and important advances in cancer and orphan drug development, including specialty generics and biosimilars...Following December’s FDA approvals of the intravenous biosimilar Lartuvo (olaratumab) for soft tissue sarcomas and the oral ovarian cancer biosimilar Rubraca (rucaparib), biosimilar and other specialty drug approvals are expected to hasten in 2017... Last year we saw a dip in...approvals but this year we are going to rebound with about 30 pending approvals...With 73 patent expirations for biologic agents by 2021, biosimilars will begin to emerge as a larger market presence in the next several years...New FDA biosimilars approvals over the next five years—including anticipated biosimilar approvals for the anti-cancer biologic agents Avastin (bevacizumab) and Herceptin (trastuzumab)—could represent a $46.2 billion market...Biologics are really acting more like competing brands, coming in at perhaps a 15% discount" compared to brand-name biologics...
- Pending approvals/patent expirations
- Recently approved specialty medications
- Specialty drug pipeline
- New PBM programs bypass insurers to offer drug discounts directly to consumers (modernhealthcare.com)
Pharmacy benefit managers and tech startups are responding to underinsurance and the onslaught of high-deductible health plans by cutting out insurers in the quest to help patients lower their prescription drug costs...Two PBMs have launched discount programs for patients to use outside of any insurance coverage they might have. It's a notable contrast to PBMs' main business serving as third-party administrators of prescription drug coverage for insurers and employers...These efforts come as a budding industry has sprung up around helping consumers and employers rein in prescription drug costs. Startups like Blink Health and RefillWise offer pharmacy cards that provide consumers with negotiated discounts if they don't use their prescription coverage, while some insurers and pharmacy benefit managers, along with tech firm Castlight Health, are attempting to allay consumer and employers' concerns about drug costs by building apps that offer price transparency to physicians or patients.
- China proposes new FDA rules to speed up foreign drug approvals (fiercepharma.com)
China's FDA published a slate of suggested amendments to its foreign drug registration rules...which could dramatically revamp the country’s pharmaceutical market landscape by eliminating hurdles that slow approvals of Western drugs. Pharma companies quickly hailed the changes...the new rules would allow foreign drugmakers to file for a new drug approval using data from international, multicenter trials, so long as those trials include China as a study site. Translation: No China-specific trial applications would be required for those foreign drugs...When finalized and implemented, these policies will encourage biopharmaceutical innovation and accelerate the approval process for new medicines...They will also pave the way for China's integration into the system for multiregional clinical trials that undergirds global drug development...
- Ohio Limits Opioid Prescriptions to Just Seven Days (msn.com)
The Ohio governor unveiled a plan...that targets the place where experts say many opioid addictions begin — the doctor's office...Gov. John Kasich's order limits the amount of opiates primary care physicians and dentists can prescribe to no more than seven days for adults and five days for minors...In addition to the pill limits, Kasich said the new rules require doctors to provide a specific diagnosis and procedure code for every painkiller prescription they write...And Kasich warned that doctors who don't follow the rules will lose their licenses...The new limits, which have gotten the blessing of the Ohio Board of Pharmacy, the State Medical Board, and the state's dental and nursing boards, do not apply to patients who take prescription painkillers for cancer treatment or to dying patients who are already receiving hospice care...As bad as things are in Ohio, it's ever worse in West Virginia, New Hampshire and Kentucky, which have even higher drug overdose death rates, according to the federal Centers for Disease Control and Prevention...Americans get hooked on locally prescribed painkillers, lawmakers say the drug cartels have made a mint feeding their habits by smuggling Chinese-made fentanyl and other opioids into the country
- Trump admin delays enforcement of 340B drug discount program rule (advisory.com)
HHS again has delayed enforcement of a final rule that would penalize drugmakers that deliberately overcharge providers for drugs purchased under the 340B drug discount program...The federal 340B program requires drug manufacturers to provide outpatient drugs to eligible health care providers at discounts ranging from 20 to 50 percent...the program has come under scrutiny, with some questioning the amount of charity care participating hospitals are providing...Under the final rule...drugmakers that "knowingly and intentionally" overcharge providers for drugs purchased through the program will face a fine of up to $5,000 per offense. The drugmakers also have to repay the overcharge...The rule took effect on Feb. 28 and was scheduled to be enforced beginning April 1...HHS again delays enforcement date...HHS in an interim rule published Monday in the Federal Register again delayed the rule's enforcement date, this time to May 22.
- Pharma’s rep with patient groups was on the rise, but not anymore: PatientView (fiercepharma.com)
It may have been too good to last. After an upswing in pharma's global reputation in 2015, its standing among patient groups has swung the other way—again. Only 38% of patient groups said the industry had either an "excellent" or "good" reputation, down from almost 45% last year...after last year’s peak, pharma scores dropped across all the measurements in PatientView's annual survey, including innovation, transparency, pricing, ethical marketing and high-quality, useful products...Almost all of the other healthcare segments...from biotech to insurers, also dropped in their esteem. The only exception was not-for-profit insurers.
- Blame President Donald Trump...with his very public criticisms of pharma "getting away with murder" and his vows to bring down drug prices.
- Then there's the ongoing pricing debate…
- ...another part of the reason for the overall declines may be that, as patient groups become a more important part of the healthcare conversation and infrastructure, they feel more confident speaking their minds...