MHAFP5032 Assignment: Policy and Pharmaceutical Regulation Presentation

MHAFP5032 Assignment: Policy and Pharmaceutical Regulation Presentation

MHAFP5032 Assignment: Policy and Pharmaceutical Regulation Presentation

Use the Capella University Library and the Internet to prepare for this assessment. Include the following activities as part of your preparation:

• In addition to reading the suggested articles listed in the Resources, perform a Web search for “oral testimony tips” to compare and contrast suggestions from more than one type of advocacy group.
• Visit the Archives and view three or four recorded oral testimonies.
  

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POWERPOINT PRESENTATION

Condense your written testimony into a 5-minute-long recorded oral presentation. Create a 3–5-slide PowerPoint to present a structure to guide your recording. Follow this structure for your presentation:

• Introductory remarks: Includes acknowledgement of committee chair and members, your credentials as the person preparing the testimony, and the organization you are representing.
• Background: Brief statement regarding justification for the proposed policy.
• Specific aspect of the issue: Summarize key points of the desired outcomes from the proposed policy with cited references. Provide a summary of current interventions for your specific issue and why additional action is needed.
• Recommendations: Provide specific recommendations for the committee and those being implemented by the special interest group.
• Concluding statement: One or two sentences summarizing why the committee should consider your proposed policy.
• Closing: Thank the committee for the opportunity and note your availability for additional discussion or questions.

ADDITIONAL REQUIREMENTS  Presentation

• Number of slides: Approximately 3–5 (length should correspond with, and not exceed, content that would amount to five minutes of oral testimony).
• Slide design: Use the notes section for your speaker notes. The slide design must meet the expectations of a professional presentation (bullet points, large font size, plenty of white space).
• Oral communication: Use persuasive oral presentation techniques such as staying on topic, integrating your slides with your presentation, and staying within the time allotment.

This is what needs to be on the PowerPoint Presentation:

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MHAFP5032 Policy and Pharmaceutical Regulation Presentation Introduction

A special acknowledgement the committee chairperson who happens to be the president and founder of Patients for Affordable Drugs, I also acknowledge the members of the committee who are boards members of the organization. This testimony has been prepared by the director of Patients for Affordable Drugs.

MHAFP5032 Policy and Pharmaceutical Regulation Presentation Background

Processes followed by pharmaceutical companies in the US are not made known to the public, and the patients have been at a disadvantage owing to the skyrocketed prices. The current pricing policy I place makes an allowance for the manufactures as there are no strict regulations that dictate the way pricing decisions are made.

In addition, brand-named products are facing no significant competition in the market, owing to the stringent approval policies of generic drugs. As of now, the FDA has in place a rigorous metric array which gauges the standards and market-worthiness of any generic drugs.

Moreover, the approval process takes time that is if a generic drug will be accepted by the FDA. All these factors bars competition in the market hence the continuous increase of drug prices in the country. The desired health policy change is centered on loosening the strictness of the FDA in terms of the generic drugs approval process.

Realizing this change will mean that new generic drugs will be easily approved, though complying with all required standards. Competition in the market will be stirred as patients will have alternatives to highly priced brand-name drugs. In response, pharmaceutical companies will be forced to standardize their drugs prices to remain competitive in the market.

Specific Aspect of the Issue

The rigorous review process used by the FDA makes it difficult for new generic drug entrants to be approved. Patents also give pharmaceutical companies market exclusivity for a considerable period, a period in which these companies take advantage and come up with outrageous prices considering they have zero competition.

A specific aspect to be zoomed in and addressed is the FDA’s process of reviewing generic drugs applications. The FDA ought to review its policies with respect to reviewing generic drugs but must also ensure integrity and quality of these products. It comes down to developing efficiency of this process.

Reducing the time taken for a generic product to be approved and reducing the market exclusivity period given to brand name drugs.

Though the exclusivity time given to these drugs is attributed to the intensive investment made by the pharmaceutical company over a long period of time so as to manufacture the drug, it is integral to consider that the government partly or fully finances medical research, and the development of new drugs is at times courtesy of the taxpayers money.

On this account, pharmaceutical companies whose researches on drugs were financed by the government ought not to be given a long exclusivity period, but rather, the drugs ought to be sold to the public at low rates.

In any case the price remains to be substantially high, the FDA should embrace leniency in reviewing generic products that are to the required standard.

Current programs and Outcomes

In the recent past, other interest groups have been advocating for reduced prescription drug prices in the country.

For example, earlier in the year, some of the states embraced change in policies that now require pharmaceutical companies to be transparent to the government and the public regarding their drug pricing process.

Some of the states that first approved this legislation are Connecticut and Maryland. In the state of Connecticut, an interest group by the name Universal Health Care Foundation of Connecticut was pivotal in creating advocacy for the transparency legislation.

As a result, insures are required to give reports to the state insurance department, elaborating on drugs prices through insure rate review procedure.

In Maryland, Maryland Citizen’s Health Initiative significantly contributed to the approval of the transparency policy whereby pharmaceutical companies are to elaborate the rationale for list prices of drugs.

Outcomes associated with the approval of these legislations are promising, as this has brought a sense of pharmaceutical companies being accountable to the state governments and the general public, getting rid of the opacity of the pricing process.

In the long run, unreasonable drug prices will be challenged if the rationale behind pricing process is not justifiable. A decrease in drug prices, on account of these new policies, is anticipated, making it easier for patients to access quality prescription drugs.

To further moderate prescription drug prices, the FDA should accelerate its generic drugs approval process so that new entrants can easily create competition in the drug market. The authority also ought to set up regulatory measures to regulate pricing of drugs depending on the authenticity of pricing rationale given by the manufactures.

Policymakers both at the state and federal levels should give ear to interest groups, constantly review policies governing health care products and services to ensure quality, service delivery and affordability of these products as offered to the general public.

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