THE EVIRONMENTAL PROTECTION AGENCY

• The Environmental Protection Agency (EPA) was established in December 1970 by an Executive order of U.S. President Nixon in response to public environmental concerns that gained momentum in the 1940s and 1960s (Jump-started by Rachel Carson's "Silent Spring" book looking at pollution in the U.S. She was a birdwatcher and discovered that heavy use of pesticides was killing off birds and making the forests "silent".).
• It is an agency of the U.S. federal government whose mission is to protect human and environmental health.
• Headquartered in Washington, DC, the EPA is responsible for creating standards and laws that promote the health of individuals and the environment.
• It seeks to protect and conserve the natural environment and improve the health of humans by researching the effects of and mandating limits on the use of pollutants.
• It regulates the manufacturing, processing, distribution, and use of chemicals and other pollutants. Also, it is charged with determining safe tolerance levels for chemicals and other pollutants in food, animal feed, and water.

Resources

There seems to be endless resources online related to the EPA. The following are samples:

https://www.epa.gov/laws-regulations
https://www.epa.gov/aboutepa
https://www.epa.gov/aboutepa/printable-epa-organization-charts-0
https://www.epa.gov/hwgenerators/management-hazardous-waste-pharmaceuticals
https://www.epa.gov/hwgenerators/management-hazardous-waste-pharmaceuticals
https://www.epa.gov/hwgenerators/management-hazardous-waste-pharmaceuticals#resources
https://www.epa.gov/rcra/medical-waste
https://www.hercenter.org/hazmat/tenstepblueprint.pdf
https://www.epa.gov/hwgenerators/final-rule-management-standards-hazardous-waste-pharmaceuticals-and-amendment-p075

Over the next few weeks, we will look closer at the EPA and hazardous waste management involving pharmaceuticals.

News

Three More Prescription Drugs Now OTC
The newly designated drugs include GlaxoSmithKline's Voltaren and two versions of Alcon's Pataday. "Approval of a wider range of nonprescription drugs has the potential to improve public health by increasing the types of drugs consumers can access and use that would otherwise only be available by prescription. This includes providing the millions of people that suffer with joint pain from arthritis daily over-the-counter access to another nonopioid treatment option," Karen Mahoney, MD, acting deputy director of the FDA's office of nonprescription drugs, said in a February 14, 2020 news release.
https://www.beckershospitalreview.com/pharmacy/fda-makes-3-prescription-drugs-available-over-the-counter.html

Pharma Execs Blast Belcher Pharmaceuticals' 600% Drug Price Hike
A group of pharmaceutical executives wrote a letter to Belcher Pharmaceuticals, criticizing the drugmaker for raising the price of dehydrated alcohol by almost 670 percent. Dehydrated alcohol has been around for decades and is used to treat chronic pain or prevent infections in patients who need nutrients intravenously.

Older versions of the drug sold by other manufacturers were never FDA approved but were available because they predated stricter FDA requirements. In June 2018, Belcher Pharmaceuticals received FDA approval for its version of dehydrated alcohol, called Ablysinol. It received orphan designation, a special status given to drugs that treat rare diseases, because Belcher asked for it to be approved to treat a rare cardiac disease. Orphan designation means other drugmakers can't market their versions of dehydrated alcohol until 2025, so Belcher's is the only kind on the market, forcing healthcare providers to pay the higher price.

Other drugmakers sold it for about $1,300 for a 10-vial pack, but Belcher is selling it for $10,000 for the same amount. Belcher justified the price hike by saying it spent "multiple millions of dollars" on developing the drug, running clinical trials and preparing its application for the FDA. But Belcher didn't run its own clinical trials. It relied on previously published research, according to an FDA review. The drugmaker did conduct its own stability studies.
https://www.beckershospitalreview.com/pharmacy/pharma-execs-blast-belcher-pharmaceuticals-600-percent-drug-price-hike.html

NCPA Warns FTC and DOJ that Vertical Mergers are Shrinking Patient Access and Trampling Smaller Competitors
The surge in vertical integration in the healthcare industry has created "an oligopoly of integrated healthcare companies controlling nearly all aspects of the healthcare and pharmacy supply chain," said the National Community Pharmacists Association (NCPA) in comments submitted to the Federal Trade Commission (FTC) and the U.S. Department of Justice (DOJ) Antitrust Division.

"These vertical mergers have allowed a handful of massive companies to exercise enormous power over patients and the marketplace. In many cases, we believe they are creating for themselves unfair advantages that are driving up patient costs and killing local businesses," said B. Douglas Hoey, NCPA CEO.

Earlier this year, the FTC and DOJ issued draft guidelines on vertical mergers in the healthcare industry. NCPA submitted comments this afternoon that point out that the three largest PBMs now control more than three quarters of all prescriptions filled in America - equaling over 3.3 billion prescriptions.

"There are 21,000 independent pharmacies in the country. That's larger than any one chain. And they are integral to the national healthcare system. In fact, in many cases, they are the only healthcare providers in their communities," said Hoey. "The big players are systematically trying to muscle them out of business. Stopping that sort of thing is exactly why antitrust protections exist, and we want the FTC and the DOJ to be more vigilant, more active, and more aggressive at enforcing them."

For more information about NCPA, please visit www.ncpanet.org

Did You Know ...

...that Winston Churchill said the following?

"I contend that for a nation to try to tax itself into prosperity is like a man standing in a bucket and trying to lift himself up by the handle."

Tip of the Week

Taxes are important for many reasons in a country like the U.S., and we benefit from them. The problem is when we see our taxes being misused and wasted. Having spent time in both federal and state governments, the observed waste is abominable! Also, many of the "giveaway programs" are misused. It seems that most people don't actually mind paying taxes as long as they are reasonable, fair, and properly used.

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Looking Back

His tenor voice
She thought divine,
Still whiskers scratched,
Sweet Adeline!
     Burma-Shave