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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...

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The FDA has suggested an Indian API maker hire a consultant that understands FDA regulations after finding the company didn’t have a grasp of some basic requirements, including how to make sure the water that comes from a nearby river is sanitary before using it to make its products...In a warning letter to Badrivishal Chemicals & Pharmaceuticals, the FDA said its plant in Maharashtra has been using the river water since 2014 without scientific evidence that the system is capable of producing water that meets quality standards...plant employees knew the water for months was out of spec for total aerobic microbial counts when it was used in production, but they didn’t investigate or even seem to understand the process that the plant’s water system relies on to kill microorganisms...water was only one of the problems FDA investigators found...Records were found in trash bags behind a building that showed test results that were different from what had been officially recorded...

British drugmakers...accused Theresa May's Conservative government of breaking a manifesto commitment to improve access to new medicines, following approval of new cost rules...The angry response from both Big Pharma and biotech firms comes despite a concession by government in the latest version of the scheme, which increases the cost threshold for certain drugs for rare diseases from the previously planned level...The row comes at a sensitive time for the government, which is about to trigger proceedings to leave the European Union but wants to encourage investment by strategic industries, including the high-tech pharmaceuticals sector...Drug companies are already concerned that Brexit could make Britain a less attractive market, especially if the country ends up outside the current EU-wide system for drug licensing...The new system means that new drugs costing the National Health Service more than 20 million pounds ($24 million) a year will no longer be automatically funded, even if they are cost-effective. Instead, companies will have to enter negotiations to justify their use and work out funding...

China has updated its list of medicines covered by national medical insurance, adding some new drugs with a focus on pediatrics and major illnesses such as cancer, hepatitis, and renal and cardiovascular diseases…The overhaul, the first since late 2009, saw the number of "Western-style" and traditional Chinese medicines included in the list grow by 15% to 2,535, among which 1,297 are Western-style meds, an 11% increase...The additions include some blockbuster meds like tenofovir, an antiviral drug to treat hepatitis B and HIV...and cancer drug gefitinib...China’s own non-small cell lung cancer med icotinib…The ministry (Ministry of Human Resources and Social Security) also put 45 drugs on a “to-be-negotiated” list, half of which are targeted cancer therapies...inclusions of new drugs would reduce the financial burden on patients and help support innovations in China's pharmaceutical market...The National Reimbursement Drug List names all the drugs covered by the insurance program, some in full and others partially. Patients must pay the full price out of pocket for those drugs outside the list, which means a huge financial burden, especially when new but more effective drugs are not covered..

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

The U.S. Department of Health and Human Services announced...that Nevada will expand mental health care services with the implementation of new community-based behavioral health care clinics...The whole idea is to try to provide better integrative care to individuals that have both substance abuse and mental disorders...We’ve never done well in this state, and probably most other states, in coordinating so that patients are getting care by the same team…the two-year Certified Community Behavioral Health Clinic...will offer 24-hour mobile crisis services, outpatient mental health and substance abuse treatment as well as recovery support.

The Nevada Senate Health and Human Services Committee heard a bill Wednesday that aims to restrict which medical professionals can administer Botox...The bill, sponsored by State Sen. Joe Hardy...would bar dental hygienists, medical assistants and aestheticians from administering botulinum toxin...one of the biggest reasons for restricting who can administer the powerful toxin is the lack of training some have in spotting infections...The bill was fiercely opposed by dental hygienists...it was unfair to categorize dental hygienists with the other professions included in the bill, claiming they have extensive training in anatomy around the head and neck...No states allow dental hygienists to administer Botox...

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.

Industry groups are taking aim at a rule created by the Food and Drug Administration that could restrict drugmakers' truthful and non-misleading promotion of its drugs — commonly referred to as off-label promotion — by expanding the evidence the agency can use to assert that a drug has been misbranded...For example, under the new rule — pertaining to the FDA's definition of intended use — if a manufacturer discovers that one of its products is being used off-label and, as a result, adjusts its supply and scales its manufacturing to meet higher demand for those off-label uses, the FDA could use the company's internal documents describing that intention to scale up as evidence of a new intended use...The agency expanded the definition of intended use to now include “totality of evidence.”...The new intended use rule exposes manufacturers to a significant risk of liability for conduct that is entirely lawful and beneficial to the public health...

Nevada Gov. Brian Sandoval said Saturday he would take his concerns about the overhaul of the Affordable Care Act to Capitol Hill where lawmakers are mulling over various proposals to replace Obamacare...The nation’s governors, in town for their annual meeting, are expected to spend Monday talking with Republican leaders and members of Congress about repeal and replacement of the health care act...Many states, including Nevada, broadened Medicaid programs to take advantage of federal funds to help insure more elderly and poor. Officials in those states are concerned about how the federal government will continue its funding commitment for the expanded programs...Sandoval said congressional overhaul of the ACA is a top concern for governors and that the “conversation is ongoing.”...