# Presentation: 192936

## 
US FDA PRESENTATION
MAY 11, 2001

- INTERNATIONAL

_**US FDA PRESENTATION**_
_**MAY 11, 2001**_
- _	_

- F R A N C E S C O

## SWITCH® Newsletter (1994)
7 years old, subscribers in 24 countries
SWITCH® Market Impact Studies (1995)
The Imminent Switch and Dual Status of Non-Sedating Antihistamines in the US (1998)
Max Planning Series
Max the Molecule® (1996)
Max the Molecule 2.0 (patent pending)

- INTERNATIONAL

- SWITCH® Newsletter (1994)
- 7 years old, subscribers in 24 countries
- SWITCH® Market Impact Studies (1995)
- The Imminent Switch and Dual Status of Non-Sedating Antihistamines in the US (1998)
- Max Planning Series
- Max the Molecule® (1996)
- Max the Molecule 2.0 (patent pending)
- _	_

- F R A N C E S C O

## We do sell our products and services to the healthcare industry
Today, we are not here representing anyone 
We are here, at our own expense,  to present our own point of view as industry experts on this important subject

- INTERNATIONAL

- We do sell our products and services to the healthcare industry
- Today, we are not here representing anyone
- We are here, at our own expense,  to present our **own point of view** as industry experts on this important subject
- _	_

- F R A N C E S C O

## Non-Sedating Antihistamines

**Non-Sedating Antihistamines**
**Are Definitely “OTCable”**

**© 2000 Francesco International**

- <footer> _**FRANCESCO**_
**INTERNATIONAL**
**4 Sloan Street,Suites C-G, South Orange, NJ 07079**
**Tele. (973) 761-5566  Fax (973) 761-6996**
***Visit us on the web at RxtoOTCSwitch.com***

## Non-Sedating Antihistamines Are Definitely “OTCable”

- The Indications for Allergy
- are universally switched as hayfever, acute or seasonal allergy
- Allergy is OTC in all markets, including conservative markets like Japan
**And these drugs are not OTC because**
**of the different distribution system...**

## DECLINE OF 3RD CLASS OF DRUGS

- Netherlands ends pharmacy only OTC’s
- UK expands GSL, reduces pharmacy only
- Canada now approves Dual after review
- GAO study finds it ineffective (1996)
- SWITCH study finds it outmoded nuisance
_***DUAL STATUS A BETTER SOLUTION***_

## So What Is The Real Issue That We Are Debating  Today?

- We are dealing with
- GRIDLOCK

## So What Is The Real Issue That We Are Debating  Today?

- We are dealing with
- The Conflicting Mandates of...
- Insurance Companies 	to	Reduce costs
- Pharma Companies	to	Max profits**
- FDA				to	Max public health

## So What Is The Real Issue That We Are Debating  Today?

- Unfortunately....
- This Panel cannot force a switch even though
- 	1)  Products & indications are appropriate
- 	2)  NSA switch saves $$ -- Canadian study
- 	3)  Broader NSA access reduces suffering
- Because of Patent Protection and Intellectual Property Laws protect the sponsors

## So What Is The Real Issue That We Are Debating  Today?

- Unfortunately....
- Your likely conclusion today will be
- “These drugs are probably safe and effective enough to gain OTC status
- 		But we need more data”
- And you may not get it!!

## So What Is The Real Issue That We Are Debating  Today?

**FACTS**
- 1)  There is little incentive to get pharma to switch the drugs earlier to the OTC market
**a)  Profitability of OTC is much less than Rx**
- 2)  _Waxman-Hatch_ extends patent life, may delay switch & may hurt what we need
_**We need self-medication enhancement,**_
_**Switch-oriented legislation to speed switch **_

## So What Is It That We Are Debating Today?

- We are dealing with
- _A major flaw in our US healthcare system__**:**_
**The inability to maximally & responsibly get safe drugs out to the public**
- Everyone here is trying to do their job
_**But -- the current Rx-to-OTC switch system isn’t helping much here today**_

## We Need to Structure Incentives for Dual Status

- Simultaneous Rx and OTC existence
- with same brand name
- with 3-6 year patent protection
- Often high dose/ low dose
- Sometimes split by indication
- International experience positive -- Germany, UK, France etc.
- US -- Pepcid, Imodium, etc.

## Dual Status Solves Stakeholder Problems

**Public** health gains from broader access **(FDA)**
**Patient** reimbursement can remain
**Consumers** can buy if they want
**Pharma** expands into new markets
**Insurance/Managed** care can save $$,
- carefully shift some cost to OTC
- or can create OTC reimbursement budget
_**Create a WIN-WIN-WIN Scenario**_

- <footer> _**FRANCESCO**_
**INTERNATIONAL**
**4 Sloan Street,Suites C-G, South Orange, NJ 07079**
**Tele. (973) 761-5566  Fax (973) 761-6996**
***Visit us on the web at RxtoOTCSwitch.com***

## Francesco International Recommendation

**PUSH THE **_**DUAL STATUS**_** CONCEPT**
-  	1)  Create legislative mechanism to encourage Dual Status
- 	2**)  **Insure understanding from all the constituencies
- 	_**LET’S AVOID GRIDLOCK AGAIN,  **_
_**MOVE OFF ALLERGY & GO ON TO.....**_

- <footer> _**FRANCESCO**_
**INTERNATIONAL**
**4 Sloan Street,Suites C-G, South Orange, NJ 07079**
**Tele. (973) 761-5566  Fax (973) 761-6996**
***Visit us on the web at RxtoOTCSwitch.com***

## INCONTINENCE
ASTHMA
HYPERCHOLESTEROLEMIA  
HYPERTENSION
OSTEOARTHRITIS
OSTEOPOROSIS 
MIGRAINE
BENIGN PROSTATE HYPERPLASIA 
VIRAL INFECTIONS
EMERGENCY CONTRACEPTION

- INCONTINENCE
- ASTHMA
- HYPERCHOLESTEROLEMIA
- HYPERTENSION
- OSTEOARTHRITIS
- OSTEOPOROSIS
- MIGRAINE
- BENIGN PROSTATE HYPERPLASIA
- VIRAL INFECTIONS
- EMERGENCY CONTRACEPTION

## F R A N C E S C O

**FDA Presentation**
**May 11, 2001**

- INTERNATIONAL