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U.S. Food and Drug Administration

Notice: Archived Document

The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.

(2)

U.S. Food and Drug Administration

Notice: Archived Document

The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.

(3)

Small Business Assistance

Financial Assistance and Incentives for Research and Development

of New Drug/Biologic Products

Ron Wilson, Director of Small Business Assistance Center for Drug Development and Research, FDA

(4)

Small Business Assistance Website

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Small BusinessAssistance/default.htm

Information for Clinical Investigators

New Drug Development and Review Process

Orphan Drug Program

Generic Drug Review Process

Over-the-Counter Drug Product Review Process

Post Drug Approval Activities

Drug Registration and Listing

Organization, Contact and Meeting Information

FDA Related Laws, Regulations, and Guidances

Economic Assistance and Incentives for Drug Development

Economic Assistance, Pre-Approval

Economic Incentives Post-Approval

(5)

Financial Assistance Pre-Approval and Financial Incentives Post-Approval

Financial Assistance Pre-Approval

Orphan Drug Program

PDUFA

Charging for Investigational Drugs

Grants

Financial Incentives Post-Approval

Orphan Drug Products Exclusivity

New Chemical Entity Exclusivity (Hatch/Waxman)

New Clinical Investigation Exclusivity (Hatch/Waxman)

Pediatric Exclusivity

(6)

Financial Assistance Pre- Approval

Orphan Drug Products

PDUFA

Charging for Investigational Drugs

Grants

(7)

Orphan Drug Program

Orphan Drug Program

Identifies orphan drug products

Facilitates their development in the

treatment of rare diseases* and conditions

*

Rare disease means any disease or condition

which affects less than 200,000 persons in the U.S http://www.fda.gov/ForIndustry/DevelopingProductsf

(8)

Orphan Drug Program

http://www.fda.gov/orphan/index.htm

Assistance Provided for Orphan Drug Designation

Tax credits

Research grants

Waiver of PDUFA application and supplement fees

Exclusivity

(9)

Prescription Drug User Fee Act (PDUFA)

Enacted in 1992

Authorizes FDA to collect fees from companies that produce certain

human drug and biological

products

(10)

PDUFA

Fees for drugs and biologics

Three types of users fees--Application Fees, Establishment Fees, and Product Fees

PDUFA Q&A for small businesses

http://www.fda.gov/Drugs/DevelopmentAp

provalProcess/SmallBusinessAssistance/u

cm069943.htm

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PDUFA

Financial Provisions of PDUFA

Waivers

Reductions

Refunds

(12)

PDUFA

Waivers

Waiver of the application fee for the first human drug application that a small business (500 or less

employees) or its affiliate submits for review is waived

Waiver may be granted to any business for one or more fees

Waiver may be granted if the assessment of the user fees would present a significant barrier to innovation due to limited resources or circumstances

(13)

PDUFA

Reductions/Refunds

Reduction or refund of fees may be

granted for an application or supplement that is refused for filing or withdrawn

before or after filing

(14)

PDUFA

Procedures for Requesting

Waiver,Reduction, or Refund of Fee

To qualify, a written request must be

submitted not later than 180 days after the fee is due

See PDUFA Q&A for specific information

on how/where to submit a request

(15)

Charging for Investigational Drugs

21CFR 312.7(d) permits sale of an

investigational drug or biological product

Certain requirements have to be met before charging is permitted

http://www.fda.gov/Drugs/DevelopmentAp

provalProcess/HowDrugsareDevelopedand

Approved/ApprovalApplications/Investigati

(16)

Grants

• Solicited grant applications

• Unsolicited grant applications

• Small Innovation Research Program

• Small Business Technology Program

• Grants & Funding Opportunities at NIH

(17)

Grants

Solicited Grant Applications

FDA solicits competitive applications through requests for applications (RFA)

RFA’s are published in the federal register and other appropriate publications.

A list of RFA’s can be found on www.grants.gov

http://www.fda.gov/AboutFDA/business/ucm119

(18)

Grants

Unsolicited Grant Applications

Unsolicited grant applications are those not submitted in response to a published request for application (RFA)

All unsolicited applications seeking FDA

support should be submitted to the Center for Scientific Review (CSR) at the NIH

http://cms.csr.nih.gov

(19)

Grants

Small Business Innovation Research Program

Requirement for Federal agencies with extramural budgets over $100 million

Set-aside program for small businesses to engage in federal R&D

Potential for commercialization and public

(20)

Grants

Small Business Innovation Program (Cont’d)

Small business is defined as having 500 or fewer employees

FDA and NIH have SBIR programs

FY 2008--FDA ($562,000 thousand) and NIH ($600M)

http://grants.nih.gov/grants/funding/sbir.htm

(21)

Commercialization Assistance Program (CAP)

NIH’s SBIR CAP Program is a nationwide

program funded by NIH for NIH SBIR Phase II awardees

10 month program designed to help some of the nation’s most promising small life science and healthcare companies develop their

businesses

(22)

Grants

Small Business Technology Transfer Program (STTR)

Requirement for Federal agencies with extramural budgets over $1 billion to administer STTR

programs

Using an annual set-aside of 0.3% for small businesses with 500 or fewer employees

(23)

Grants

STTR Program (Cont’d)

Objective similar to SBIR

Unique feature is the requirement for the small business applicant organization to formally collaborate with a research

institution

At least 40% of the STTR research project

is to be conducted by the small business

(24)

GRANTS

SBIR and STTR Program Structure

Phase l: Establishes technical merit and feasibility of the proposed R/R&D efforts

Phase ll: Continues R&D efforts initiated in phase I with award of additional support

Phase III: Pursue with non-SBIR and STTR funds the commercialization of objectives resulting from phase I/II R/R&D activities

(25)

SBIR/STTR Conference

Annual NIH

SBIR/STTR conference

A two-day annual conference for

small businesses conducting innovative health-related research

htp://nbdc.unomaha.edu/sbir/nihconference/home.htm

(26)

Grants and Funding Opportunities at NIH

• Grants

• Research Contracts

• NIH Guide for Grants and Contracts

• Research Training Opportunities

• http://grants.nih.gov/grants/oer.htm

(27)

Financial Incentives Post- Approval

Orphan Drug Products Exclusivity

New Chemical Entity Exclusivity (Hatch- Waxman)

New Clinical investigation Exclusivity (Hatch- Waxman Exclusivity)

Pediatric Exclusivity

(28)

Exclusivity

Exclusivity generally bars FDA approval or acceptance of certain applications for

competing drugs.

Exclusivity runs from date of approval.

Concurrent with protection (if any), except

for pediatric exclusivity which attaches to

an existing exclusivity or patent period.

(29)

H atch/Waxman 5 Year Exclusivity

Purpose was to encourage research and development of new drugs

5-year period of exclusivity is granted to new drug products containing chemical entities never

previously approved by FDA either alone or in combination

No 505(b)(2) application or ANDA may be

submitted during the 5-year exclusivity period

Full new drug applications under 505(b)(1) and

(30)

Hatch/Waxman 3 Year Exclusivity

A 3-year period of exclusivity is granted for a change in an approved drug product.

Approval requires new clinical investigations (other than bioavailability studies)

Examples of the changes in an approved drug product that affect its active ingredient(s) are new indication, strength, dosage form, route of administration

For 3 years FDA may not approve an ANDA (505)(j) or 505(b)(2) for the protected change

http://www.fda.gov/downloads/Drugs/GuidanceComplianc eRegulatoryInformation/Guidances/UCM079345.pdf

(31)

Pediatric Exclusivity

Six months exclusivity as an incentive to sponsors to conduct more studies of the use of drug in pediatric populations

Attaches to the END of all existing marketing exclusivity and patent periods. Hatch/Waxman-exclusivity, orphan drug

exclusivity, and patent periods run concurrently

Only drug products subject to section 505 of the Food, Drug and Cosmetic Act are eligible for pediatric exclusivity

Pediatric Drug Development –

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Dev elopmentResources/ucm049867.htm

(32)

Generic Drug Exclusivity (180-day Exclusivity)

180 days of exclusivity for first ANDA applicant to file a complete application, successfully challenge listed

patent and receive FDA approval

The agency has proposed new regulations in the

implementation of the 180-day exclusivity. Have not been published.

http://www.fda.gov/Drugs/DevelopmentApprovalProces s/SmallBusinessAssistance/ucm069964.htm

(33)

Patent Term Extension

Up to 5 years of patent extension for creating innovative products that benefit the public. Includes most products regulated by FDA including drugs and biologic

Must be the first commercial marketing or use of the product under the provision of the law which such regulatory review occurred

FDA assists patent trademark office (PTO) in determining a products eligibility for patent extension. PTO is responsible for determining the period of patent extension

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Sm allBusinessAssistance/ucm069959.htm

(34)

Other Federal Assistance

• Small Business Administration federal grant resources – http://www.sba.gov

• www.grants.gov

• The Catalog of Federal Domestic Assistance

• www.gsa.gov/fdac/

• NIAID Biodefense Research

• www.niaid.nih.gov

(35)

Hollings Manufacturing

Extension Partnership (MEP)

• Hollings Manufacturing Extension Partnership with NIST provides technical and business

assistance to smaller manufacturers.

• MEP is a national network with hundreds of specialists who understand the needs of manufacturers

(36)

SCORE

• The SCORE Association (Service Corps of

Retired Executives) is a resource partner of the SBA dedicated to entrepreneur education and the formation, growth and success of small

businesses nationwide.

• There are more than 10,500 SCORE volunteers in 374 chapters operating in over 800 locations who assist small businesses with business

counseling and training. SCORE also operates an active online counseling initiative.

• http://www.score.org/index.html

(37)

Small Business Assistance ListServ

What's new for small pharmaceutical businesses:

Receive email notification of new information (federal register notices, guidances,

workshops, etc.)

Small Business Assistance Website provides the link--

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/

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