- Trump’s first budget seeks to slash $6B from NIH, raise FDA user fees (fiercebiotech.com)
President Donald Trump’s first budget will take $5.8 billion away from the National Institutes of Health, around 20% of its total, with FDA user fees also set to rise as biopharmas should "pay for their share."...The budget cut to the NIH...had around $30 billion in funds last year...The NIH...got a funding boost just last year when the 21st Century Cures Act was passed, a law that allowed the Institute an extra $4.8 billion in funding over the next decade...There was no direct mention of FDA cuts, but use fees are set to potentially double..Recalibrates Food and Drug Administration medical product user fees to over $2 billion in 2018, approximately $1 billion over the 2017 annualized CR level, and replaces the need for new budget authority to cover pre-market review costs. To complement the increase in medical product user fees, the Budget includes a package of administrative actions designed to achieve regulatory efficiency and speed the development of safe and effective medical products...
- Indian Drugmakers Seek to Sway Trump Over Cheap Generic Imports (bloomberg.com)
India’s largest pharmaceutical firms are looking to convince U.S. President Donald Trump that his promise to lower drug costs should take priority over his vow to make sure the medicines are made in America...Savings from cheaper imported drugs will outweigh the jobs created by producing them in the U.S., the Indian Pharmaceutical Alliance...said in a report...One goal could be to win an exemption for generic drugs under any border-tax policy that is enacted in the U.S….Indian companies recommend their government highlight the firms’ investments in the U.S., where the largest companies have increased their presence in recent years in an attempt to diversify their manufacturing base...Closer collaboration with the FDA is also recommended to help the industry solve deficiencies in manufacturing practices that have prompted a wave of sanctions from the regulator in recent years, hurting the industry’s reputation and sales…..The approach should be to project India as a reliable and trustworthy source for access to safe and quality medicines at affordable prices.
- R&D Costs For Pharmaceutical Companies Do Not Explain Elevated US Drug Prices (healthaffairs.org)
That pharmaceutical companies charge much more for their drugs in the United States than they do in other Western countries has contributed to public and political distrust of their pricing practices. When these higher US prices...are challenged, the pharmaceutical industry often explains that the higher prices they charge in the US provide them with the funds they need to conduct their high-risk research...This claim—that premiums earned from charging US patients and taxpayers more for medications than other Western countries funds companies’ research—is empirically testable...We found...charging substantially higher prices...in the US compared to other Western countries generates substantially more than the companies spend globally on their research and development...Importantly, our analysis cannot inform the question whether or not it is appropriate for US patients, taxpayers, and businesses to bear the burden of funding pharmaceutical research for the world...
- Lawmakers Introduce Prescription Drug Importation Bill to Ease High Costs (pharmacytimes.com)
Senators Bernie Sanders, Cory Booker, and Bob Casey introduced a new bill this past week that would allow the importation of prescription medications from licensed Canadian pharmacies. The legislation, named the Affordable and Safe Prescription Drug Importation Act, would permit the United States to import medications from Canada, where drug spending is significantly lower…The bill outlines importation provisions including safeguards and consumer protections, such as FDA certification of foreign sellers, a clear definition of what drugs may be imported, and supply chain security requirements. Imported drugs must have the same active ingredient, route of administration, and strength as its US-approved counterpart...Previous importation proposals have been shot down due to safety concerns, but supporters of the new bill note added safety measures…Pharmaceutical Researchers and Manufacturers of America released a statement condemning prescription drug importation, due to the potential of counterfeit drugs entering the United States that could put American patients at risk...Even drugs that supposedly come from Canada are frequently not made or processed there, but actually come from counties with lax regulatory systems.
- How a Major Drugmaker Plans to Cure Disease… Without Drugs (fool.com)
Hacking into the body's nervous system may allow GlaxoSmithKline to commercialize an entirely new field of medicine...GlaxoSmithKline plc has the resources to pursue long-term bets in medicine that could eventually change the course of disease treatment and yield large payoffs...to literally eavesdrop on the body's electrical system and enter into the body's own internal conversations in order to heal disease...every organ has a nerve connection that regulates its function. Organs are controlled by patterns of electrical impulses transmitted through nerve fibers, but when organs dysfunction in chronic disease, the electrical patterns are different. That fact opens up the possibility that inserting patterns in nerves to certain organs can correct conditions that lead to disease...scientists are just beginning to realize the possibilities of using nerve signals to restore organs to normal function and actually treat disease...Bioelectronic medicines have the potential of doing to the pharmaceutical industry what biopharmaceuticals did to small molecules back in the 1980s…
- Express Scripts challenges Gilead in pricing blame game (biopharmadive.com)
Comments from Gilead Sciences’ head of worldwide commercial operations last week to Bloomberg have reignited a furious debate within the industry over who is to blame for rising drug costs...Gilead’s Jim Meyers told the publication that pharmacy benefit managers are to blame for keeping drug prices high...But PBM Express Scripts fired back this week with a letter to Gilead CEO John Milligan urging the company to cut the cost of its hepatitis C drugs and even pay back the difference retroactively...Meyers' comments insinuated PBMs keep drug prices high in order to inflate their own revenues through the cut they take from rebates and discounts given by manufacturers...Express Scripts...has taken particular offense to these accusations...The request from Express Scripts was a bold one and unlikely to materialize in Gilead paying back its profits. Yet, the public back-and-forth adds another dynamic to who may be to blame for high drug prices...
- Drug Costs Too High? Fire the Middleman (bloomberg.com)
Caterpillar’s lowered drug bills show why pharmacy benefit managers are under fire. A decade ago, Caterpillar Inc. looked at its employee drug plan and sensed that money was evaporating... By hiring its own doctors and pharmacists, among other changes, Caterpillar has saved tens of millions of dollars a year...The model is as successful today as it’s ever been...Caterpillar’s move away from benefit managers started when it suspected that as much as a quarter of its $150 million drug spending was wasted. The company devised its own list of drugs to offer its U.S. health-plan members and negotiated deals with pharmacies. It promoted generics and discouraged use of expensive heartburn and cholesterol medicines. The changes have saved the company $5 million to $10 million per year on cholesterol-lowering statins alone...Drug spending at Caterpillar...has dropped per patient and per prescription since the company started the program...
- New UK drug cost rules leave companies fuming (reuters.com)
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...
- 5 trends changing clinical trials (biopharmadive.com)
Clinical trials have become increasing costly ventures, adding to the overall cost of developing a drug and, ultimately, the price that patients pay for drugs. A 2016 estimate by the Tufts Center for the Study of Drug Development, for example, pegged average clinical trial costs across all three phases of development at roughly $340 million in out-of-pocket expenses. Big pharmas and small biotechs alike are looking for innovative ways to improve trial outcomes and, in turn, lower trial costs — this means increasing the efficiency in which they recruit patients, monitoring more closely how drugs are supplied and being more flexible about trial design. Here’s a look at some of the tools that are optimizing clinical trials today:
- Patient centricity
- Tapping into technology
- Data you can wear
- Flexibility
- Automated site supplies
- Pharmaceutical Inspections in Europe, US to Get New Framework (pharmacytimes.com)
The US FDA and the European Union took an important step forward this week in pharmaceutical manufacturer inspection collaboration, completing an exchange of letters that will allow the FDA and EU drug inspectors to rely upon information from drug inspections conducted within each other’s borders...the letters, which will amend the Pharmaceutical Annex to the US-EU Mutual Recognition Agreement, will enable the FDA and EU to "avoid the duplication of drug inspections, lower inspection costs and enable regulators to devote more resources to other parts of the world where there may be greater risk...The Mutual Recognition Agreement is an important step in working collaboratively and strategically with key partners to help ensure that American patients have access to safe, effective and high quality drugs…