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Ronna B. Hauser, PharmD, vice president of pharmacy affairs for the National Community Pharmacists Association, provides an overview of some of the most important aspects of the Drug Quality and Security Act.

Australia is altering its drug laws to allow for the cultivation of marijuana for medicinal and scientific purposes, removing a major hurdle to the establishment of clinical trials of the drug, the government said…Draft amendments to the Narcotics Drugs Act are being finalised to allow for the controlled cultivation of marijuana, giving patients access to "a safe, legal and sustainable supply of locally produced products for the first time,"…Australian manufacturers, researchers and patients currently have to access international supplies of legal medicinal marijuana, with cost, limited supply and export barriers making this challenging.

American Pharmacists Association…announced that The Pharmacy and Medically Underserved Areas Enhancement Act reached an important milestone in the House of Representatives, having a majority of members support the legislation…"This is a crucial moment in the public debate on how to improve health care access and how to reduce America's health care costs,"…."National surveys show Americans believe pharmacists are integral members of their health care team. Now, the majority of the House has stated that they agree."

Laws that allow terminally ill patients access to experimental drugs are gaining momentum across the USA, but experts say they could do more harm than good…the right-to-try laws...are designed to circumvent the FDA…proponents of the laws view the agency's bureaucracy as a roadblock, not a pathway, for desperate patients seeking experimental drugs. "When patients are almost willing to try anything to live…we shouldn't see government stand in the way"…Critics...say the laws are misguided, that drug companies, not the FDA, restrict the availability of experimental drugs because of cost, limited supplies, or concerns about the effect on clinical trials…skeptics believe the laws could do more harm than good, possibly raising false hopes about drugs whose safety and effectiveness have not yet been proven…

In their Perspective article…Avorn and Kesselheim argue that the 21st Century Cures Act, which is currently being debated in Congress, would lower the regulatory standards of the Food and Drug Administration by giving it greater discretion to approve drugs on the basis of less rigorous data…the legislation would authorize the FDA to "rely" on observational analyses, which are less rigorous than randomized controlled trials. But the Cures Act does not diminish the FDA's standards for requiring that new medical products are safe and effective. Rather, it recognizes that recent developments in genomics, systems biology, electronic data systems, and other fields can provide additional tools and resources to support better premarketing and postmarketing regulation and more efficient development of drugs and medical devices…Better evidence and up-to-date regulatory science are the best foundation for regulatory decisions and meaningful progress in biomedical innovation. They are also the best way to avoid turning back the clock on new opportunities to develop safe and effective treatments for unmet medical needs...

A trio of bills aimed at bringing order and oversight to California’s medical marijuana industry…This new structure will make sure patients have access to medical marijuana, while ensuring a robust tracking system…seeks to manage medical marijuana by requiring individuals or companies engaged in any aspect of the industry to obtain at least one of 17 different licenses…The legislation includes separate licenses for indoor and outdoor cultivation, transportation, product testing, distribution and dispensaries of different sizes. It...charges various state agencies to develop guidelines for packaging, potency, pesticide use and advertising…sets up a medical marijuana bureau,..allows the state to issue licenses to pay for oversight,…cracks down on clinics that specialize in issuing medical marijuana licenses for people without valid health needs...

California wants to cap drug prices, but Big Pharma isn't having it. Amid a growing backlash over drug pricing, companies such as Johnson & Johnson and Bristol-Myers Squibb are funneling millions of dollars into stamping out a new proposal that would curb drug spending in the state…other companies including Pfizer, Eisai, Purdue Pharma, The Medicines Co., Sunovion Pharmaceuticals and Daiichi Sankyo contributed to a fund that would quash a state ballot initiative…The initiative, dubbed the California Drug Price Relief Act, would only allow government health programs to strike contracts with drugmakers at prices that are the same or lower than those paid by the Department of Veterans Affairs, which usually gets steep discounts on meds from manufacturers…

New Jersey governor…took action…by signing a bill aimed at prohibiting the sale of medications containing dextromethorphan,…found in…over-the-counter cold medications, to any person under the age of 18 unless they have a prescription. New Jersey is the ninth state to implement a law restricting the sale of DXM-containing products…"The enactment of similar legislation in states across the country has indicated that limiting teen access to DXM is a proven way to prevent abuse,"…"We are confident that this law will further allow parents to prevent abuse among their children, while continuing to ensure access for the millions of adults and families who responsibly use products containing DXM to treat common cough symptoms."

California Governor…Brown…signed a bill that sets the strictest government standards in the United States for the use of antibiotics in livestock production…. comes amid growing concern that the overuse of such drugs is contributing to rising numbers of life-threatening human infections from antibiotic-resistant bacteria known as "superbugs."… Veterinary use of antibiotics is legal…consumer advocates, public health experts and investors have become more critical of the practice of routinely feeding antibiotics to chickens, cattle and pigs…The bill…will restrict the regular use of antibiotics for disease prevention and bans antibiotic use to fatten up animals…aims to stop over-the-counter sale of antibiotics for livestock use…antibiotics would have to be ordered by a licensed veterinarian…California's Department of Food and Agriculture will be required to monitor antibiotic sales and use.

Nick Gentile, Director of State Grassroots Advocacy and Political Action for ASHP, discusses different legislative issues generating buzz on the state level, including biosimilars.