[Pharmwaste] Flawed NYS Medication Take-Back Bill: Media Coverage & more

[Ed Gottlieb]

Three stories were recently published about the deeply flawed NYS chain pharmacy medication take-back bill (A.387-B) that passed both houses and could be sent to Gov. Cuomo anytime now.
Please ask Gov. Cuomo to veto this bill (see previous post, below).  Thank you!  Ed G.

STAT Pharmalot blog posted on Aug 31 by Ed Silverman (full blog, and link, posted below).

Link to the 9/4 story in Albany Times-Union paper:
http://www.timesunion.com/allnews/article/Drug-take-back-plan-draws-critics-12167451.php<http://www.timesunion.com/allnews/article/Drug-take-back-plan-draws-critics-12167451.php>

Link to the 9/6 story on the American Pharmacists Association website:
http://www.pharmacist.com/article/medication-take-back-plan-draws-critics

Opinion:
PhARMA's legal challenge to the first product stewardship law failed and their lobbying to stop new product stewardship bills from passing has been largely unsuccessful.  The NY Chain Pharmacy bill is the unveiling of a new PhARMA strategy:  State legislation that puts the cost of take-back on consumers and chain pharmacies while preempting existing and future local laws that require manufactures to pay.  To keep pharmacies from strongly objecting, the bill exempts independent pharmacies and allows chain pharmacies to pass on some of the cost to consumers.

The NY bill has several short comings that severely limit its effectiveness, most notably:
1. It treats an occasional one day collection event and $2 mail back envelopes as equivalent in convenience to installing a drop-box.  Free to use drop-boxes are far more user friendly than limited capacity, high cost, envelopes or a one day event.
2. The lack of chain pharmacies in rural areas leaves many unserved by this legislation.
I'd like to address a couple of points from the STAT blog:

STATEMENT: Quoting the bill’s sponsor, Senator Kemp Hannon:
“I’m trying to be pragmatic. I did not want to get up caught up in court cases that almost for sure we’d get from the pharmaceutical industry. I wanted to get a system up and running as quickly as possible to get opioids out of circulation if they’re no longer being used for medicinal purposes. But this is not the end of the game.”
RESPONSE: PhARMA unsuccessfully challenged Alameda County, California’s take-back bill. The U.S. Supreme Court refused to hear the industry’s case, leaving the Ninth Circuit Appeals Court ruling, that the law was valid, in place.  Since then, many similar laws have passed at the local and state level and there have been no more legal challenges.  There is no reason to believe a manufacturer funded product stewardship law in NY would be challenged in court.  A manufacturer funded program could place free mail back envelopes in pharmacies just as quickly as this legislation will make $2 envelopes available.

STATEMENT: "Meanwhile, the New York lawmakers who championed the bills maintain there is ongoing interest in having drug makers underwrite a take-back program. A separate bill<http://nyassembly.gov/leg/?default_fld=&leg_video=&bn=A08432&term=2017&Summary=Y&Text=Y> was recently introduced that requires a study for creating a program that would be financed by the pharmaceutical industry, and it would have to be submitted to state officials by May 2018."
The referenced bill, [http://nyassembly.gov/leg/?default_fld=&leg_video=&bn=A08432&term=2017&Summary=Y&Text=Y<http://nyassembly.gov/leg/?default_fld=&leg_video=&bn=A08432&term=2017&Summary=Y&Text=Y>]
"Directs the department of health to conduct a prescription drug product stewardship disposal program study, whereby such department shall study and report on the feasibility of establishing incentives to consumers to return controlled substances and other prescription drugs for safe disposal."
RESPONSE: We already know the best "incentives" for consumer participation in take-back programs: free, convenient drop-off at pharmacies (who voluntarily participate) and mail-back envelopes for those who are home-bound or otherwise find it difficult to get to a pharmacy. Then, promote the program. This bill is not necessary and should be replaced by a producer responsibility bill based on models we know work. Neither the study bill nor the chain pharmacy take-back bill will be effective.

Of Note:  The Business Council of New York State is opposed to this legislation.
Pharma may win a big victory in New York over a drug take-back program
https://www.statnews.com/pharmalot/2017/08/31/take-back-program-new-york/
By ED SILVERMAN<https://www.statnews.com/staff/ed-silverman/> @Pharmalot<https://twitter.com/Pharmalot>  AUGUST 31, 2017

In what could be a big win for the pharmaceutical industry, legislation is close to being signed into law in New York State that would absolve drug makers from paying for so-called drug take-back programs.

Identical bills<http://assembly.state.ny.us/leg/?default_fld=&leg_video=&bn=S06750&term=2017&Summary=Y&Text=Y> recently passed the state Senate and Assembly that would, instead, require chain pharmacies to cover the costs, a move that bucks a growing trend on the West Coast, where drug makers have increasingly been forced by local governments to pay for these programs.
Over the past few years, four California cities and 12 counties in California and Washington created programs requiring drug makers to foot the bill. And ordinances are expected in still more California counties, according to Heidi Sanborn of the California Product Stewardship Council. But the trend has also headed eastward as Cook County, Ill., and Rockland County<http://rocklandgov.com/files/6814/9029/1262/local_law_2_of_2017.pdf>, N.Y., recently passed similar laws.
Local officials are pursuing such ordinances in the face of rising disposal costs, growing concerns about contaminants in water supplies, and a desire to reduce the threat of drug abuse stemming from medicines — especially opioids — lingering in cabinets. And they have been emboldened after the U.S. Supreme Court let stand<https://blogs.wsj.com/pharmalot/2015/05/26/pharmaceutical-industry-must-pay-for-drug-take-back-programs/> the legality of the first such ordinance, which was passed in 2012 in Alameda County, Calif.
This explains why environmental activists are disheartened by the developments in New York.
Besides Rockland County, two other New York counties are considering ordinances that would require drug makers to pay for take-back programs, but all of these efforts would be pre-empted by a state law. And such a law would represent a significant gain for the pharmaceutical industry, since New York would stand in stark contrast to the mostly failed attempts to derail ordinances in California.
“It would be a significant development,” said Scott Cassel, who heads the Product Stewardship Institute, a nonprofit that supports drug take-back programs. “We’re seeing the pharmaceutical industry try different strategies to get out of any responsibility for managing these leftover medications.”
Indeed, industry trade groups unsuccessfully went to court to prevent Alameda County from implementing its ordinance. Last year, however, the trade group scored a victory in Los Angeles County, which tabled<http://publichealth.lacounty.gov/docs/PharmaMotion_11_22_2016.pdf> a law that would have required drug makers to finance a take-back program, according to a spokeswoman for the Los Angeles County Board of Supervisors.
A spokeswoman for the Pharmaceutical Research & Manufacturers of America declined to comment. A spokesman for the National Association of Chain Drug Stores wrote to say the trade group is having “ongoing discussions regarding the specifics … and its potential implementation.”
Meanwhile, the New York lawmakers who championed the bills maintain there is ongoing interest in having drug makers underwrite a take-back program. A separate bill<http://nyassembly.gov/leg/?default_fld=&leg_video=&bn=A08432&term=2017&Summary=Y&Text=Y> was recently introduced that requires a study for creating a program that would be financed by the pharmaceutical industry, and it would have to be submitted to state officials by May 2018.
This prompted frustration, however, from Ed Day, the Rockland County executive. “It’s a cost shifting exercise,” he said. “This is conjecture, but it would seem to me that the impact on the local economy would be greater if the cost were borne by chains than large manufacturers… But there should be common sense — stop now and know what you wish to do before you implement something.”
But one of the New York lawmakers argued otherwise.
“I’m trying to be pragmatic. I did not want to get up caught up in court cases that almost for sure we’d get from the pharmaceutical industry,” said Kemp Hannon, a Republican who heads the Senate Health Committee. “I wanted to get a system up and running as quickly as possible to get opioids out of circulation if they’re no longer being used for medicinal purposes. But this is not the end of the game.”
Separately, the New York State Association of Counties supports the legislation.
For what it’s worth, Hannon last year received<https://www.followthemoney.org/show-me?c-t-eid=6587420&d-cci=68&y=2016#%5B%7B1%7Cgro=d-eid> $29,750 from drug makers, according to the National Institute on Money in State Politics. He scoffed that this influenced the process. “In the course of this bill pending, I didn’t get any comments from pharmaceutical people,” he said. Assemblywoman Aileen Gunther, who introduced the companion bill, received<https://www.followthemoney.org/show-me?c-t-eid=6462454&d-cci=68&y=2016#%5B%7B1%7Cgro=d-eid> $2,000 last year, from different drug makers.
Ed Gottlieb
Chair, Coalition for Safe Medication Disposal
Board Member, New York Product Stewardship Council
Industrial Pretreatment Coordinator
Ithaca Area Wastewater Treatment Facility
525 3rd Street
Ithaca, NY  14850
(607) 273-8381
fax: (607) 273-8433

PREVIOUS POST (8/24):
Any day now, a seriously flawed New York State chain pharmacy take-back bill could be signed into law.  https://www.nysenate.gov/legislation/bills/2017/a387/amendment/b
It would do a poor job of providing convenient take-back and who pays for it is wrong.

This could be the leading edge of a wave of state bills that shield manufactures from any responsibility for the collection and disposal of their unwanted products.  To prevent this, we need to take action!  (Suggestions highlighted below.)

The bill requires pharmacies with 10 or more stores in the state to offer take-back options (plural in the NY bill).  Pharmacies could choose among any legal method, including:  mail-back, home disposal products, collection events (no frequency specified), and kiosks.

It appears that the original Senate version of the bill required that all take-back be free to consumers.  It was amended to allow the pharmacies to pass on 100% of the cost of mail-back envelopes to consumers.  The final version, amended by the Assembly, allows them to pass on up to $2 of the cost of mail-back envelopes to consumers, with other take-back options remaining free.  Does your inner cynic wonder, as mine does, if the change from "free" to "pay 100% for mail-back" was a bait and switch to get the support of legislators?
My interpretation of the bill is that it would be easy for chain pharmacies to comply with the law.  They could sell small take-back envelopes for $2 and sponsor a once-a-year collection event.  When I spoke with representatives of a couple of chain pharmacies, they were supportive of the compromise version because it releases them from having to install kiosks, which take more effort and are seen as a liability risk (something EPR bills need to address!).

The bill does nothing to increase take-back in rural areas without a chain pharmacy.

The bill also preempts local law, so existing EPR laws will be struck down.  This totally relieves manufactures of any responsibility to organize or pay for take-back and puts the full burden on chain pharmacies and consumers.

If you don't live in NY and want to see an effective pharmaceutical EPR law in your community or state, or don't want to see your local EPR law disappear, please educate state legislators about EPR now.* If they don't get the facts, a state chain pharmacy bill will probably look like a good compromise solution.
If you are a New Yorker, please ask Governor Cuomo to veto A.387-B, the chain pharmacy take-back bill.  It could be sent to his desk for a signature any time, so contact him right away!  He will have to hear from many of us to consider a veto, the bill had strong, bipartisan support.
Talking points:
•        This bill is a give-away to the pharmaceutical manufactures, relieving them of any responsibility for the collection and disposal of their unwanted product.  Chain pharmacies and consumers will have to pay for take-back.
•         It fails to provide effective take-back of unwanted household medications.
o    Charging $2 for a small mail-back envelope is a strong disincentive to participate.
o    Many rural communities are not served by chain pharmacies.  This bill does nothing for them.
•         Without convenient take-back options, medicine cabinets will continue to fuel the opioid addiction crisis, accidental poisonings, and environmental contamination.
•         It preempts any local law related to take-back.  Rockland County’s extended producer responsibility (EPR) law, will no longer be valid.  Similar bills, including those under consideration in Erie and Westchester Counties, will be moot.  The only reason for preemption is to ensure that manufactures won’t have to pay.
•         MA & VT, along with many municipalities, have passed pharmaceutical EPR laws.  NY should improve upon those models and take the lead on this important public health issue!
Contact Governor Cuomo's office by phone:  1-518-474-8390<tel:15184748390>  Hours: 9:00am to 5:00pm
Web form: https://www.governor.ny.gov/content/governor-contact-form
Write:
The Honorable Andrew M. Cuomo
Governor of New York State
NYS State Capitol Building
Albany, NY 12224
* Here are a couple of links to information on EPR:

http://www.productstewardship.us/?page=GoToGuide
http://calpsc.org/products/pharmaceuticals/
Thanks for speaking out!

Ed Gottlieb
Chair, Coalition for Safe Medication Disposal
Board Member, New York Product Stewardship Council
Industrial Pretreatment Coordinator
Ithaca Area Wastewater Treatment Facility
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