FDA proposes regulations for meetings between agency, biosimilar makers
SILVER SPRING, Md. — The Food and Drug Administration is seeking comment from drug makers and others concerning formal meetings between the agency and companies looking to market follow-on biologics.
The agency’s Center for Drug Evaluation and Research announced Friday the release of draft guidance titled "Guidance for Industry: Formal Meetings Between the FDA and Biosimilar Biologic Product Sponsors or Applicants." The agency said the purpose of the guidance was for comment purposes only, and it did not reflect current regulations. An abbreviated approval pathway for follow-on biologics was enacted as part of the Patient Protection and Affordable Care Act of 2010, but regulations have yet to be finalized.
The FDA said the regulations were needed to ensure efficient, consistent procedures for meetings between the agency and drug makers, whether they take place face to face, via teleconference or video conference.
The draft guidance proposes five different types of meetings: Biosimilar Initial Advisory meetings, which discuss the feasibility of a proposed product; Biologic Product Development Type 1 meetings, to discuss issues like clinical holds, special protocols and safety issues; BPD Type 2 meetings, to discuss specific issues such as proposed study designs or study endpoints; BPD Type 3 meetings, which are in-depth data review and advice meetings; and BPD Type 4 meetings, to discuss the format and content of a product application.
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Pharmaca introduces travel vaccination, health consultation program
BOULDER, Colo. — Pharmaca Integrative Pharmacy on Thursday expanded its immunization offering to include travel vaccinations along with a comprehensive list of health services related to traveling abroad.
Pharmaca patients can now schedule an appointment for any of the following vaccinations: hepatitis A and B, tetanus, typhoid, meningitis, Tdap, yellow fever (though not in Colorado locations), varicella and rabies. Pharmaca still offers vaccinations for flu, shingles, whooping cough and pneumonia on a walk-in basis.
Patients can also schedule a pre-travel health consultation with the pharmacist at a cost of $60 for an individual and $100 for a couple. According to the company’s travel site, consultations include help determining which vaccinations are required or recommended for the particular travel destination, a discussion of remedies and best practices for staying healthy while there, a complete report on the destination that includes a detailed summary of pharmacist recommendations around safety and health considerations, and proof of immunizations.
Collaborative practice agreements: Where we are and where we’re going
A decade ago, the Journal of the American Pharmacists Association published a study that examined the state of collaborative practice. In 2003, 32 states had pharmacist collaborative practice regulations. Of those, 23 states allowed pharmacists to initiate and modify drug therapy. The study found that collaborative practice had a positive effect on pharmacist-doctor relationships, and on patients’ perceptions of pharmacists.
The past decade has seen a wider adoption of collaborative practice. According to the National Alliance of State Pharmacy Associations, in 2012, a total of 46 states had some form of collaborative practice protocols between pharmacists and physicians. These agreements are typically regulated by state boards of pharmacy and medicine, or scope of practice acts. Collaborative practice agreements allow pharmacists to provide a wide range of clinical patient care services in partnership with other healthcare professionals, usually physicians. Patient care services may include selecting, initiating, administering, monitoring, modifying or discontinuing medication therapy, and much more. However, the exact extent to which a pharmacist can provide these services varies widely depending on state regulations.
The value of pharmacists as part of the healthcare team has been growing steadily, and the federal government (i.e., Centers for Medicare and Medicaid Services) has shown increasing interest in pharmacist-provided services to improve patient outcomes. With this backdrop, in January 2012, the American Pharmacists Association Foundation held a roundtable consortium to discuss the role of pharmacists in patient care and the increased use of collaborative practice agreements. The results of the roundtable, a white paper titled “Consortium recommendation for advancing pharmacists’ patient care services and collaborative practice agreements,” will appear in the March/April 2013 issue of JAPhA.
The roundtable included participants from pharmacy, medicine and nursing from 12 different states. The purpose was to develop recommendations on how to adopt and integrate pharmacist patient care activities and CPAs into practice. The group came up with seven recommendations:
Use consistent terminology and language that is readily understandable by all potential audiences.
Allow healthcare providers who enter into the CPAs to define the details of each agreement. This may require regulatory or legislative changes to allow practitioners the flexibility to develop their own CPAs. Roundtable participants felt that current laws limiting the scope of CPAs also limited patient care.
Create and expand an infrastructure that embeds pharmacists’ patient care services and CPAs into care, while creating ease of access for patients. In other words, make the process seamless and easy for patients, and create a business model supporting the pharmacists’ role.
Incentivize and facilitate the adoption of electronic health records and the use of technology in pharmacists’ patient care services. Electronic health records and other technology will make it easier for healthcare providers to share information with each other.
Encourage pharmacists to maintain strong, trusting and mutually beneficial relationships with patients, physicians and other providers; encourage those individuals to promote the pharmacist’s patient care services — networking, marketing and promotion.
Properly align incentives based on meaningful process and outcome measures for patients, payers, providers and the healthcare system.
Provide incentives, financial or otherwise, to patients and providers based on outcomes.
Examine and redesign health professionals’ practice acts, education curriculums and operational policies to create synergy, promote collaboration and optimize support staff. For example, the whitepaper suggests that teaching providers about the roles of other health professionals can help build a team mentality and a focus on collaboration.
Collaborative practice holds great promise for the future, particularly when it comes to chronic disease or patients with multiple health problems. The APhA Foundation roundtable was a great start in terms of recommendations; states, however, may need to change their policies and regulations to allow CPAs to be all that they can be.
Ann W. Latner, JD, a former criminal defense attorney, is a freelance medical writer in Port Washington, N.Y.
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