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President Obama has signed a law that resets approval dates for some medicines that contain controlled substances. The goal is to streamline the process used by the Drug Enforcement Agency to place prescription drugs that are controlled substances on a list of medicines for which distribution is restricted…the new law ensures that a company offering such medications will not effectively lose time from a five-year period under which it can exclusively market the drugs…Drug makers have griped they are often at a competitive disadvantage, since controlled substances must first be placed on the DEA list before they can reach pharmacies. Companies have complained the process is often lengthy and hampers their ability to take advantage of a five-year marketing exclusivity period following Food and Drug Administration approval during which generic competition is delayed…the Improving Regulatory Transparency for New Medical Therapies Act, would require the DEA to list a drug within 90 days after receiving notice from the FDA...

Governor John Kasich signed OPA-backed maximum allowable cost pricing and pharmacy benefit manager reforms into law. These reforms will better enable pharmacies to be kept whole on the medications they purchase and dispense to patients…While the law is now in effect, we expected the rollout to bring many questions and perhaps some foot-dragging by a few in the PBM industry, and as expected, it appears we're getting some of both. See below for a complete guide on the new law, implementation of the law, and what to do if you are working with a PBM who is failing to comply with the law.

• What are the new laws?
• How will the new laws be enforced?
• How do pharmacies register complaints if the law is not being followed?

We are pleased to report that it seems several PBMs seem to be embracing the spirit of the law so far, however we are hearing that not all PBMs are in compliance.

As drug price increases continue to make waves on the national level, Congress is taking the matter into its own hands by requiring generic drugmakers under the Medicaid Drug Rebate Program to pay higher rebates if generic prices rise too quickly…The new penalty for such price increases on generics, which is included in the recently passed budget deal, basically amounts to additional rebates that generic drug manufacturers would have to pay if the price of a generic for a given quarter outpaces the inflation-adjusted baseline Average Manufacturer Price…Under the Bipartisan Budget Act of 2015, the additional rebate...would now be applied to generics, too, beginning in Q1 of 2017...the change could create issues for generic manufacturers around updating their Medicaid price reporting systems, figuring out the potential financial impact of the change, and posing new strategic pricing questions for generic drug launches and market withdrawals.

For those concerned about the rising cost of pharmaceuticals, Congress is proposing some relief. The two-year budget deal proposed by lawmakers this week unexpectedly includes a provision that would require generic drug makers to pay additional rebates to state Medicaid programs for any medicine that increases in price faster than the inflation rate…The cost of new medicines for hard-to-treat diseases, such as cancer and hepatitis C, worry public and private payers, who call them budget busters. And there is growing outrage at companies such as Valeant Pharmaceuticals and...Turing Pharmaceuticals for buying drugs and then boosting the prices to sky-high levels.

In New Jersey, a bill (A2477) authorizing pharmacists filling a prescription for a biological medication to select an interchangeable biological product, was signed into law…A substitution cannot be made if the prescriber indicates that there shall be no substitution. The law requires the New Jersey State Board of Pharmacy to maintain a link on its website to FDA’s current list of interchangeable biological products. Further, the law requires a pharmacist or designee to notify the prescriber of the biological product dispensed, including the name of the product and the manufacturer, within five days…The pharmacist is also required to record on the prescription label, and record of dispensing, the product name of the interchangeable biological product, followed by the words “Substituted for” and the name of the biological medication for which the prescription was written, and the manufacturer of the interchangeable biological product.

A bill under which the government would have gained responsibility for repurposing off-patent medicines showing promise in unlicensed indications has failed to make it past its second reading in parliament…The …is seeking to make the Secretary of State for Health responsible for securing new licences for unprotected medicines where there is evidence of their effectiveness in new indications…the Bill…could, over time, “revolutionise access to treatments across a whole range of medical conditions”, as currently, there is no incentive for pharmaceutical companies to seek new licenses for old drugs that are no longer patent protected, meaning that in cases where they could be effective against other diseases patients would only get access through off-label prescriptions…the government is instead pursuing a non-legislative solution to the issue of off-patent drugs…

Texas Medical Association wants Congress to intervene and make changes to the federal electronic health-record incentive payment program it's calling "meaningless abuse."…The group says Stage 3 of the program meant to get physicians using EHRs could jeopardize Medicare doc payment rules… wants Congress to lift what it's describing as the $31.6 billion program's “convoluted and tedious” meaningful-use requirements…TMA President Dr. Tom Garcia asked legislators to co-sponsor two bills to alter the meaningful-use landscape…One is the Flex-IT 2 Act...which would delay Stage 3 meaningful-use rules until at least Jan. 1, 2017. The other is the Transparent Ratings on Usability and Security to Transform Information Technology, or TRUST IT Act which is aimed at ensuring health IT systems perform better in the field.

California and Oregon…will soon make access to birth control easier for millions of women by allowing them to obtain contraceptives from pharmacists without a doctor’s prescription…Most Western countries require a doctor’s prescription for hormonal contraceptives…but starting sometime in the next few months, women in California and Oregon will be able to obtain these types of birth control by getting a prescription directly from the pharmacist who dispenses them, a more convenient and potentially less expensive option than going to the doctor…Pharmacists will be authorized to prescribe contraceptives after a quick screening process in which women fill out a questionnaire about their health and medical histories…pharmacists’ organizations, plan to lobby for it across the country…One unanswered question, however, is whether insurers will pay for the time pharmacists spend reviewing women’s questionnaires or helping evaluate options. To cover that cost, some pharmacists may charge fees...The laws in Oregon and California differ in some ways. California’s has no age restriction; the Oregon law requires that teenagers under 18 obtain their first contraceptive prescription from a doctor. In California, pharmacists will also most likely have to take women’s blood pressure for contraceptives containing estrogen.

Thousands of pages of the final text of the 12-nation Trans-Pacific Partnership trade deal were released by the White House…in hopes of persuading critics to come out in favor of it. But those hopes were dashed when critics from all walks of the economy in the U.S. and elsewhere criticized the provisions…critics ranged from Ford to environmental groups to U.S. nurses and Malaysian officials concerned about potential cost increases on lifesaving drugs that will affect patients who could suffer when lower-cost generics take years longer to come on to the market…National Nurses United union said in a statement that the TPP "is even worse than prior reports had predicted" and said monopoly pricing protections for pharmaceutical companies "could be a death sentence for countless patients in need of affordable medications around the world."...

Ohio Pharmacists Association, the state organization representing Ohio’s pharmacist practitioners, announced their opposition to the Ohio Marijuana Legalization Initiative, Issue 3, which if passed which would place legalized marijuana and a protected oligopoly of select commercial marijuana growers into the Ohio Constitution…OPA is unconvinced that marijuana is appropriate or beneficial as a form of treatment for illness or disease. Further, OPA rejects any medical marijuana proposal that removes the function, counsel, and expertise of the prescriber and pharmacist from the prescription process, as Issue 3 does…“If there is going to be a legitimate discussion about marijuana policy or the possible effectiveness of marijuana for medical purposes, then let’s have it. But ‘Responsible Ohio’ bypasses the discussion altogether in an effort to benefit to a few wealthy investors. Issue 3 is a slap in the face to Ohioans who genuinely care about sensible marijuana policy.”